Patients must not have an uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, severe infection, severe malnutrition, unstable angina, class III-IV New York Heart Association (NYHA) congestive heart failure, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within 6 months prior to step 2 randomization
The subject has an uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure (New York Heart Association class III or IV), active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, chronic liver or renal disease, or severe malnutrition
Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration (New York Heart Association [NYHA] classification III-IV)
Unstable angina, congestive heart failure [NYHA (New York Heart Association) >class II], uncontrolled hypertension [diastolic > 100 mmHg], uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction, uncontrolled diabetes mellitus
The participant has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association class III or IV, active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, severe malnutrition or psychiatric illness/social situations that would limit compliance with study requirements
The subject has an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association class III or IV, active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, chronic liver or renal disease, or severe malnutrition
The participant has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association class III or IV, active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, severe malnutrition or psychiatric illness/social situations that would limit compliance with study requirements
Participants who have an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association class III or IV, active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, chronic liver or renal disease, or severe malnutrition; in addition, patients are ineligible if they have a psychiatric illness or a social situation that could limit their ability to comply with the study requirements
Any other severe, uncontrolled medical condition, including uncontrolled diabetes mellitus (defined as a Hemoglobin A1C ? 9% in subjects with a prior history of diabetes, 28 days prior to study registration) or unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification)
The participant has an uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure (New York Heart Association class III or IV), active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, chronic liver or renal disease, or severe malnutrition
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to: History of immune deficiencies or autoimmune disease; Myocardial infarction or arterial thromboembolic events within 6 months prior to screening or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTc interval > 470 msec; Uncontrolled hypertension or diabetes mellitus; Another known malignancy that is progressing or requires active treatment; Active infection requiring systemic therapy; Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema).
Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including but not limited to:\r\n* Uncontrolled infection\r\n* New York Heart Association (NYHA) III or IV heart failure\r\n* Crohn’s disease or those with ulcerative colitis who have not undergone a colectomy\r\n* Known active infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Uncontrolled illness including but not limited to: symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV heart failure), unstable angina pectoris, uncontrolled cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician
Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association (NYHA) class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B, C or HIV, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; in addition, subjects will be excluded for any of the following:\r\n* Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease\r\n* History of documented congestive heart failure (New York Heart Association functional classification III or IV)\r\n* Documented history of cardiomyopathy\r\n* Uncontrolled hypertension (systolic blood pressure [SBP] > 160/diastolic blood pressure [DBP] > 100 despite medical intervention)\r\n* History of myocarditis of any etiology\r\n* History of cardiac surgery\r\n* History of ventricular arrhythmias
Uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, severe infection, severe malnutrition, unstable angina, class III-IV New York Heart Association (NYHA) congestive heart failure, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within 6 months prior to enrollment
Current evidence of active and uncontrolled infection, NYHA Class III-IV CHF, documented Child's class B and C cirrhosis, active pancreatitis or uncontrolled medical disease which in the opinion of the investigator could compromise assessment of efficacy.
Uncontrolled concurrent disease or illness including but not limited to: symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV) per the NYHA classification, unstable angina pectoris, clinically significant cardiac arrhythmia; unstable or untreated cardiac conditions or ejection fraction of < 50% as determined by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA); diabetes mellitus (i.e. fasting blood glucose > 220 despite acceptable chronic diabetes therapy); psychiatric illness that would limit compliance with study requirements, as determined by the investigator.
New York Heart Association class II - IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
Uncontrolled intercurrent medical condition including, but not limited to:\r\n* Uncontrolled infection\r\n* Symptomatic congestive heart failure (New York Heart Association [NYHA] class III-IV)\r\n* Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening\r\n* Uncontrolled cardiac arrhythmia or arrhythmia requiring medication other than beta blocker\r\n* Psychiatric illness/social situations that would limit compliance with study requirements\r\n* Any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, etc.)
Other serious illness or medical condition within 6 months before enrollment, including any of the following: Concurrent congestive heart failure NYHA Class III or IV, severe/unstable angina pectoris, myocardial infarction, uncontrolled hypertension, coronary/peripheral artery bypass graft, high-risk uncontrolled arrhythmias, stroke.
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality (eg, QTcF >470 msec)
Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant ECG abnormality (eg, QTcF >470 msec)
Current evidence of active and uncontrolled infection, New York Heart Association (NYHA) class III-IV congestive heart failure (CHF), documented Child’s class B-C cirrhosis, active pancreatitis or uncontrolled medical disease which in the opinion of the investigator could compromise assessment of efficacy
Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:\r\n* Any uncontrolled infection\r\n* Cardiac failure NYHA (New York Heart Association) III or IV\r\n* Crohn’s disease or ulcerative colitis\r\n* Bone marrow dysplasia\r\n* Known allergy to any of the compounds under investigation\r\n* Unmanageable fecal incontinence
Subjects must have evidence of adequate cardiac function, as defined by the following: absence of New York Heart Association (NYHA) class II, III, or IV congestive heart failure; absence of uncontrolled angina or hypertension; absence of myocardial infarction in the previous 6 months; absence of clinically significant bradycardia, or other uncontrolled cardiac arrhythmia defined as grade 3 or 4 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association [NYHA] class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association [NYHA] class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Uncontrolled inter-current illness including, but not limited to ongoing or active infection (> grade 2 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] version 4.0), congestive heart failure (> New York Heart Association (NYHA) class 2), active coronary artery disease (CAD), cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin), uncontrolled hypertension and any condition which could jeopardize the safety of the patient and his/her compliance in the study; myocardial infarction more than 6 months prior to screening is permitted
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study; examples include, but are not limited to: \r\n* Uncontrolled diabetes defined as fasting serum glucose > 1.5 x ULN\r\n* Uncontrolled hypertension, or greater than 150/100 in spite of antihypertensive therapy\r\n* Active (acute or chronic) or uncontrolled severe infection\r\n* Unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association Class III or IV), ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months\r\n* Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Has uncontrolled clinically significant cardiac disease, including myocardial infarction within 6 months before date of study entry or unstable or uncontrolled angina, congestive heart failure, New York Heart Association (NYHA) Class III-IV, uncontrolled cardiac arrhythmia (Grade 2 or higher).
Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association (NYHA) class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B, hepatitis C or HIV, or other significant co-morbid conditions that, in the opinion of the Investigator, would impair study participation or cooperation.
Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (?grade 2, according to NCI CTCAE v4.03), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent medical illness that in the opinion of the investigator would preclude protocol therapy.
Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, psychiatric illness that would limit compliance with study requirements, or active heart disease including confirmed myocardial infarction within previous 3 months, symptomatic coronary artery disease, clinically significant arrhythmias not controlled by medication, or uncontrolled congestive heart failure New York (NY) Heart Association class III or IV
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; as infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control; myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, uncontrolled hypertension, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration (New York Heart Association [NYHA] classification III-IV)
Patients must not have clinically significant illness including uncontrolled, active infection requiring intravenous antibiotics, New York Heart Association (NYHA) class III or class IV heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled >= grade 3 cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus; patients must have undergone an electrocardiogram (EKG) within 28 days prior to registration
Active and uncontrolled disease/(active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association [NYHA] class III/IV, clinically significant and uncontrolled arrhythmia) as judged by the treating physician
Concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the investigator, such as but not limited to:\r\n* Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease, or a QTCB (corrected according to Bazett's formula) interval > 470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)\r\n* Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy\r\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association class [NYHA] class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study
Known significant cardiac abnormalities including:\r\n* Congestive heart failure, New York Heart Association (NYHA) class III or IV\r\n* Uncontrolled angina, arrhythmia or hypertension\r\n* Myocardial infarction within the past six months\r\n* Any other uncontrolled or severe cardiovascular condition\r\n* Prior cerebrovascular event with residual neurologic deficit
New York Heart Association class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as active angina pectoris, clinically significant cardiac arrhythmia that requires therapy in the opinion of the treating physician or PI, uncontrolled hypertension (blood pressure > 160 systolic and > 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus in the opinion of the treating physician or PI, or uncontrolled congestive heart failure in the opinion of the treating physician or PI
Uncontrolled intercurrent illness including but not limited to: ongoing or active infection, systemic congestive heart failure class III or IV by New York Heart Association (NYHA) criteria, unstable angina pectoris, or cardiac arrhythmia, or in patients status post allogeneic transplantation with uncontrolled graft versus host disease (GVHD)
Patients with evidence of severe or uncontrolled systemic disease, or any concurrent condition, which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies, uncontrolled hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection unless sustained virologic response to HCV therapy, uncontrolled diabetes, serious non-healing ulcer, wound or bone fracture, history of intra-abdominal abscess, abdominal fistula or gastrointestinal perforation within 28 days of treatment, history of pulmonary embolism in the past 12 months, uncontrolled hypertension, myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry, class III or IV heart failure as defined by the NYHA functional classification system, stroke/cerebrovascular accident or transient ischemic attack within the past 12 months or psychiatric illness/social situations which would jeopardize compliance with the protocol
Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTcB (corrected according to Bazett's formula) interval > 470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
Significant cardiac disease including myocardial infarction or unstable angina within 6 months, uncontrolled hypertension despite medical therapy (defined as blood pressure > 160/110 in spite of adequate medical therapy), active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, stroke within preceding 6 months
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (less than the last 6 months), cardiac arrhythmia, history of cerebrovascular accident (CVA) within 6 months; no uncontrolled hypertension (defined as blood pressure of > 160/90 mmHg) on medication or, history of peripheral vascular disease
New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >= 160 systolic and >= 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure
Any uncontrolled medical illness that precludes the patient from undergoing a biopsy for molecular profiling and/or receiving treatment under one of the experimental arms of the study should be excluded; these conditions include but are not limited to:\r\n* Ongoing or uncontrolled, symptomatic congestive heart failure (class III or IV as defined by the New York Heart Association [NYHA] functional classification system)\r\n* Uncontrolled hypertension\r\n* Unstable angina pectoris\r\n* Cardiac arrhythmia\r\n* Uncontrolled diabetes\r\n* Uncontrolled psychiatric illness/social situations that would limit compliance with study requirements
Serious uncontrolled medical disorder or active systemic infection or current unstable or decompensated medical condition, which makes it undesirable or unsafe for the patient to participate in the study including: New York Heart Association (NYHA) Class 3 or 4, myocardial infarction within 3 months, uncontrolled angina within 3 months, history of clinically significant ventricular arrhythmia, diabetes mellitus with ketoacidosis, or chronic obstructive pulmonary disease (COPD) requiring hospitalization in 6 months prior to the start of treatment with PRI-724.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), or unstable angina pectoris
Any condition precluding exercise, including: New York Heart Association (NYHA) class II, III, or IV congestive heart failure, uncontrolled angina, myocardial infarction in the prior 12 months, orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the study period, chronic pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, symptomatic anemia, uncontrolled psychiatric conditions such as schizophrenia, or any other comorbidity that would interfere with the ability to complete and comply with the study protocol in the opinion of the investigator
Uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, congestive heart failure-New York Heart Association class III or IV, active ischemic heart disease, myocardial infarction within the previous six months, uncontrolled diabetes mellitus, gastric or duodenal ulceration diagnosed within the previous 6 months, chronic liver or renal disease, severe malnutrition or psychiatric illness/social situations that would limit compliance with study requirements
Has a serious concurrent medical condition, such as: congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening, 12-Lead electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant including myocardial infarction, angioplasty, or cardiac stent placement within the last 6 months, HIV infection, known Hepatitis B or C infection. Subjects at high risk for Hepatitis B or C infection should have serology testing to rule out infection, a medical condition requiring the therapeutic use of anticoagulants.
Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG)
Subjects must not have an uncontrolled intercurrent illness, including an ongoing or active infection, current pneumonitis, symptomatic congestive heart failure (New York Heart Association class III or IV), unstable angina, uncontrolled hypertension, cardiac arrhythmia, interstitial lung disease, active coagulopathy, or uncontrolled diabetes.
Clinically significant cardiopulmonary disease including uncontrolled or New York Heart Association (NYHA) class 3 or 4 congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infarction or stroke within 6 months of first protocol treatment, or corrected QT (QTc) > 480 ms
Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG)
Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG)
The patient has New York Heart Association (NYHA) class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, or congestive heart failure.
Symptomatic congestive heart failure (NYHA class ? II);
Patients with chronic kidney disease (glomerular filtration rate [GFR] < 60), uncontrolled hypertension, congestive heart failure, pre-existing bone marrow dysfunction, or cytopenias\r\n* Congestive heart failure (CHF): New York Heart Association (NYHA) class II-IV at the time of screening
Patients with any class of New York Heart Association (NYHA) congestive heart failure (CHF) or heart failure with preserved ejection fraction (HFPEF)
New York Heart Association (NYHA) Class II or higher congestive heart failure.
New York Heart Association heart failure class >= 3
Adequate cardiac function (?New York Heart Association [NYHA] Class II).
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or ejection fraction < 40% by multigated acquisition (MUGA) scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI)
congestive heart failure > class II NYHA,
New York Heart Association (NYHA) functional class =< 2
Other clinically significant heart disease (New York Heart Association [NYHA] class 3 heart failure, uncontrolled hypertension)
Patients with a previous history of adriamycin treatment and are at risk of cardiac failure (New York Heart Association [NYHA] class II or above)
New York Heart Association (NYHA) cardiac class 3-4 heart disease
Congestive heart failure > New York Heart Association (NYHA) class 2
Congestive heart failure > New York Heart Association (NYHA) class 2
Symptomatic heart failure NYHA Class ? 3
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or ejection fraction < 40% by MUGA scan or < 50% by echocardiogram and/or magnetic resonance imaging (MRI)
New York Heart Association (NYHA) class II or higher congestive heart failure
Congestive heart failure (CHF) NYHA Class ? 3, or
Documented New York Heart Association (NYHA) class I, II and III
Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines (Appendix D).
New York Heart Association class 3-4 heart failure
New York Heart Association (NYHA) cardiac class 3-4 heart disease
Congestive heart failure New York Heart Association (NYHA) class 3 or 4
Patient with active heart disease (New York Heart Association [NYHA] class >= 3 as assessed by history and physical examination)
Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2
Heart failure > New York Heart Association (NYHA) class II
Clinically stable in New York heart association (NYHA) class 2 or 3 for the 3 months preceding screening Inclusion Criteria for Group 2
Subjects who were diagnosed with New York Heart Association (NYHA) Class II congestive heart failure or have clinically significant arrhythmia not controlled by medication prior to study entry.
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions
History or evidence of current >= class II congestive heart failure as defined by New York Heart Association (NYHA)
Documented New York Heart Association (NYHA) class I, II and III
Congestive heart failure > New York Heart Association (NYHA) class II
New York Heart Association (NYHA) class 3 or 4 congestive heart failure (CHF) symptoms
New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
Congestive heart failure of any severity (New York Heart Association [NYHA] class I-IV)
New York Heart Association (NYHA) class II or higher congestive heart failure
Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ? 45%.
New York Heart Association (NYHA) class II or higher congestive heart failure
No New York Heart Association Class > II congestive heart failure
Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF < 50%, as measured by MUGA scan or echocardiogram)
NYHA ? Class 2.
Congestive heart failure - New York Heart Association (NYHA) > Class II.
Congestive heart failure greater than NYHA Class II
Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure
New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
Patients with history of myocardial infarct within 6 months before enrollment, New York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious for congestive heart failure are not eligible unless a Left ventricular ejection fraction (LVEF) in the past 6 months is documented to be 50% or greater; patients who have had a LVEF (performed for any reason) that is less than 50% in the past 6 months are ineligible
New York Heart Association (NYHA) Class II or higher congestive heart failure.
Congestive heart failure > New York Heart Association (NYHA) class 2
Any known unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or ejection fraction < 45% by echocardiogram, or cardiac magnetic resonance imaging (MRI)
Congestive heart failure, defined as New York Heart Association (NYHA) Class II, within 3 months before C1D1 (see Appendix 1).
Congestive heart failure > class II New York Heart Association (NYHA) or unstable angina
New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
Prior anthracycline treatment and at risk of cardiac failure (New York Heart Association Class 2)
Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ? 45%.
Active congestive heart failure (New York Heart Association [NYHA] class II-IV)
The following groups of patients are eligible provided they have New York Heart Association class II (NYHA) cardiac function on baseline echocardiogram (ECHO)/multi gated acquisition scan (MUGA):\r\n* Those with a history of class II heart failure who are asymptomatic on treatment\r\n* Those with prior anthracycline exposure\r\n* Those who have received central thoracic radiation that included the heart in the radiotherapy port
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction < 50% by multi-gated acquisition (MUGA) scan or by transthoracic echocardiogram
Major cardiac dysfunction, such as uncontrolled angina, congestive heart failure with New York Heart Association (NYHA) class III or higher, known left ventricular ejection fraction less than 40%
Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.
Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF)
Patients with New York Heart Association (NYHA) heart failure class > 2
-  Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.
History of congestive heart failure New York Heart Association (NYHA) class 3 or 4 in the past, unless a screening echocardiogram or multi-gated acquisition scan performed within three months results in a left ventricular ejection fraction that is ? 45%;
Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association ([NYHA] Appendix G) ? Class 2
Patient with active heart disease (New York Heart Association [NYHA] class greater than or equal to 2 as assessed by history and physical examination)
Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure
Class II-IV New York Heart Association (NYHA) congestive heart failure
congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.
Subject has current symptomatic heart failure or a history of congestive heart failure New York Heart Association (NYHA) class 3 or 4
New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
A history or evidence of current >=Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines
Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
Clinically evident congestive heart failure > class II of the NYHA guidelines.
Subject has congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subject with a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram performed within 3 months prior to study entry results in a left ventricular ejection fraction that is ? 45%
Symptomatic heart failure – New York Heart Association (NYHA) class >= II symptoms
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions and/or known ejection fraction < 40% by multi gated acquisition scan (MUGA) or < 50% by echocardiogram and/or magnetic resonance imaging (MRI)
History of cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II
Congestive heart failure of New York Heart Association (NYHA) class III or higher severity at study entry
A history or evidence of current >=Class II congestive heart failure as defined by the New York Heart Association (NYHA)
Patients with a history of congestive heart failure of any New York Heart Association class
Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within three months of the Screening visit results in a left ventricular ejection fraction that is ? 45%
The following groups of patients are eligible after consultation with a cardiologist and at the coordinating center PI’s discretion, provided they have New York Heart Association class II (NYHA) cardiac function on baseline echocardiogram (ECHO)/multigated acquisition scan (MUGA):\r\n* Those with a history of class II heart failure who are asymptomatic on treatment\r\n* Those with prior anthracycline exposure greater than a cumulative dose of 350 mg/m^2\r\n* Those who have received central thoracic radiation that included the heart in the radiotherapy port
Patients with New York Heart Association (NYHA) class II-IV heart failure
Cardiac failure, New York Heart Association (NYHA) Class II according to the NYHA Functional Classification,
Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.
History of congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4;
Uncontrolled heart failure as defined by New York Heart Association (NYHA) class 3 or 4
Clinically significant cardiac disease defined by congestive heart failure New York Heart Association (NYHA) Class 3 or Class 4.
History of New York Heart Association Class 3 or 4 heart failure;
Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification
Congestive heart failure of New York Heart Association Class ? 3 or known left ventricular ejection fraction < 40%, or
Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject has a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 1 month prior to study entry results in a left ventricular ejection fraction that is ? 45%.
Confirmed left ventricular ejection fraction ?50% or any cardiac insufficiency > New York Heart Association (NYHA) class II currently or within the past 6 months,
Clinically significant cardiac disease (New York [NY] Heart Association class III or IV), including chronic arrhythmia, or pulmonary disease
Active angina pectoris or NY Heart Association Class III-IV
Any clinically-significant cardiac disease defined as New York Heart Association class III or IV within the past 6 months of Screening, unless, in the opinion of the Investigator, the disease is well-controlled
TREATMENT EXCLUSION: Symptomatic cardiac disease (New York Heart Association [NYHA] class III or IV disease)
Uncontrolled coronary disease or New York Heart Association (NYHA) class III-IV heart disease
The patients must not be candidates for chemotherapy due to at least one of the following reasons:\r\n* Performance status of 2\r\n* Creatinine clearance =< 60 ml/min as calculated by the Cockcroft-Gault formula\r\n* Cardiac disease such as New York Heart Association (NYHA) class III or IV heart failure or cardiac ischemia within the last 12 months, grade 2 or greater neuropathy, or other comorbidities based on which patient is not considered a candidate for chemotherapy
New York Heart Association (NYHA) Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition.
Cardiac failure New York Heart Association (NYHA) III or IV Crohn’s disease or ulcerative colitis
New York Heart Association (NYHA) class III or IV heart disease
Major cardiovascular or pulmonary comorbidity that precludes use of general anesthesia (NYHA [New York Heart Association] class III and IV)
Serious intercurrent chronic or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment
Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication
Clinically significant heart disease, defined as New York Heart Association (NYH) class III or IV
Severe cardiac insufficiency (New York Heart Association [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
Patients with serious intercurrent chronic or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the principal investigator as unwarranted high risk for investigational drug treatment
Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of < 35%
Patients with clinically significant heart disease (NYHA Class III or IV).
Uncontrolled coronary disease or New York Heart Association (NYHA) class III-IV heart disease
Significant cardiac disease (New York Heart Association classes III or IV) or unstable angina despite medication;
Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV)
Evidence of New York Heart Association (NYHA) functional class III or IV heart disease
Adequate cardiac functions assessed by 2 dimensional (D) echocardiography (ECHO).\r\n* (New York Heart Association [NYHA] cardiac III-IV excluded).
Clinically significant cardiac disease, including major cardiac dysfunction, such as uncontrolled angina, clinical congestive heart failure with New York Heart Association (NYHA) class III or IV, ventricular arrhythmias requiring anti-arrhythmic therapy
Evidence of New York Heart Association (NYHA) functional class III or IV heart disease
Clinically significant cardiac disease (New York Heart Association, class III or IV)
Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease
Evidence of New York Heart Association (NYHA) functional class III or IV heart disease
Subjects who have a history or current evidence of uncontrolled cardiovascular disease i.e. NYHA (New York Heart Association) Class III or IV.
Normal cardiac function\r\n* No active coronary artery disease\r\n* No New York Heart Association class II, III or IV disease\r\n* No arrhythmia requiring treatment\r\n* Baseline echocardiogram with a shortening fraction of >= 27% or an ejection fraction >= 50%
New York Heart Association class III or IV cardiovascular disease
New York Heart Association Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition
No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease
Evidence of New York Heart Association (NYHA) functional class III or IV heart disease
Clinically significant cardiac disease (New York [NY] Heart Association class III or IV), including chronic arrhythmias, or pulmonary disease
Patients with New York Heart Association class 3 or 4 disease
Clinically significant cardiac disease (New York [NY] Heart Association class III or IV) or pulmonary disease
New York Heart Association (NYHA) class III or IV heart disease
Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease
Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease
Any clinically significant cardiac disease defined as NYHA class III or IV.
DONOR: History of severe cardiovascular disease, defined as New York Heart Association class III or IV
New York Heart Association (NYHA) class III or IV; NOTE: patients classified as NYHA class II controlled with treatment may participate, with increased monitoring
Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria.
No New York Heart Association (NYHA) class III or IV heart disease
Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria.
Normal cardiac function:\r\n* No active coronary artery disease\r\n* No New York Heart Association class II, III, or IV disease\r\n* No arrhythmia requiring treatment
Clinically significant heart disease (New York Heart Association [NYHA] class III or IV) within six months
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
Have with history of severe cardiac disease (New York Heart Association functional class III or IV)
Severe cardiac disease (New York Heart Association class III or greater)
Severe cardiac insufficiency (New York Heart Association class [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
New York Heart Association class III/IV cardiac disease
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)
New York Heart Association Class II-IV congestive heart failure
Any of the following cardiac abnormalities:\r\n* Unstable angina pectoris\r\n* Congestive heart failure >= New York Heart Association class 3\r\n* Corrected QT interval (QTc) >= 470 milliseconds calculated using Fridericia‘s correction\r\n* Current or history of pericardial effusion causing hemodynamic compromise
Diagnosis of symptomatic congestive heart failure (New York Heart Association [NYHA] II-IV) or symptomatic or poorly controlled cardiac arrhythmia
Known cardiac disorder, including:\r\n* Known inherited coronary disease\r\n* Symptomatic heart failure (New York Heart Association [NYHA] class II-IV prior or current cardiomyopathy, or severe valvular heart disease)\r\n* Current cardiomyopathy\r\n* Severe valvular heart disease\r\n* Atrial fibrillation\r\n* Ejection fraction (ECHO) < 53%\r\n* QTcF > 450 msec
Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF < 50%, as measured by MUGA scan or echocardiogram)
Subjects with a history of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly controlled angina, or history (< 1 year prior to enrollment) of ventricular arrhythmia
Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment Has a corrected QT by Fridericia's formula (QTcF), of >470 ms based on a triplicate 12-lead ECG
Symptomatic congestive heart failure (New York Heart Association class >= 2) within the 6 months prior to study drug administration
Has symptomatic congestive heart failure (New York Heart Association [NYHA] Classes II-IV), unstable angina, or cardiac arrhythmia requiring antiarrhythmic treatment.
New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, stable or unstable angina, symptoms of coronary artery disease, congestive heart failure, clinically significant hypotension, or history of an ejection fraction of =< 30 % (echocardiogram or multi gated acquisition scan [MUGA])
New York Heart Association > Class II congestive heart failure that is not controlled on standard therapy within 6 months prior to initiation of treatment with Toca 511.
New York Heart Association class III or greater congestive heart failure within last 6 months or uncontrolled hyperlipidemia (cholesterol > 300 mg/dl; triglyceride 2.5 X upper limit of normal [ULN] despite lipid lowering agent) within last 3 months
Have clinical symptomatic congestive heart failure defined at >= Class II of the New York Heart Association functional classification system or LVEF < 50% at baseline.
Symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia; symptomatic heart failure (New York Heart Association [NYHA] class II-IV)
History of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia).
Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia requiring treatment
New York Heart Association class II/III/IV congestive heart failure with a history of dyspnea, orthopnea, or edema that requires current treatment with angiotensin convering enzyme inhibitors, angiotensin II receptor blockers, beta-blockers, or diuretics
Significant cardiovascular abnormalities as defined by any one of the following: \r\n* Congestive heart failure New York Heart Association (NYHA) classes II-IV; patients with asymptomatic class I congestive heart failure (CHF) may participate in conjunction with a cardiology consultation\r\n* Clinically significant hypotension\r\n* Symptoms of coronary artery disease\r\n* Presence of arrhythmias in electrocardiography (EKG) requiring drug therapy
Current congestive heart failure (New York Heart Association class II-IV).
For Cohort A: Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease), unstable angina pectoris, cardiac arrhythmia, or uncontrolled hypertension
have congestive heart failure or poorly controlled cardiac arrhythmia per New York Heart Association Class II-IV heart disease
Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
Any clinically significant pericardial effusion, congestive heart failure (CHF) (New York [NY] Heart Association grade II-IV) or cardiovascular condition that would preclude assessment of mesothelin induced pericarditis or that may worsen as a result of toxicities expected for this study; this determination will be made by a cardiologist if cardiac issues are suspected
History or evidence of current ?Class II congestive heart failure as defined by New York Heart Association.
Subjects with clinically significant heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly controlled angina, or history (< 1 year) of ventricular arrhythmia
The participant has symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, stable or unstable angina, symptoms of coronary artery disease (CAD), congestive heart failure, clinically significant hypotension or history of an ejection fraction of =< 30% (echocardiogram or multi-gated acquisition scan [MUGA])
Severe cardiovascular disease including symptomatic angina pectoris, symptomatic cardiac arrhythmia, or symptomatic congestive heart failure (New York Heart Association class II-IV); subjects carrying a diagnosis of congestive heart failure which is asymptomatic are eligible so long as a baseline and follow-up echocardiogram are performed as per the study calendar
Significant cardiovascular disease including congestive heart failure (New York Heart Association class II or higher) or active angina pectoris
Patients with myocardial impairment of any cause (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging)
Patients must not have a history of cardiac disease, defined as New York Heart Association class II or greater or clinical evidence of congestive heart failure
Patients must not have a history of cardiac disease, defined as New York Heart Association class II or greater or clinical evidence of congestive heart failure; all patients must have a MUGA scan or 2-dimensional (D) echocardiogram indicating an ejection fraction of >= 45% within 42 days prior to registration; the method used at baseline must be used for later monitoring
Other clinically significant heart disease (e.g. congestive heart failure [CHF] New York [NY] Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy
History of documented congestive heart failure (CHF), New York Heart Association class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics; NOTE: use of these medications for the treatment of hypertension is allowed
Class II-IV congestive heart failure, as defined by the New York Heart Association
New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, stable or unstable angina, symptoms of coronary artery disease, congestive heart failure, clinically significant hypotension, or an ejection fraction of =< 40 % (echocardiogram or MUGA)
Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
Other clinically significant heart disease (e.g., congestive heart failure (CHF) New York (NY) Heart Association class II or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
Have congestive heart failure (CHF) New York Heart Association class ?3 or symptomatic or poorly controlled cardiac arrhythmia.
Current congestive heart failure (New York Heart Association Class II-IV).
Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging)
History of cardiac heart failure of New York Heart Association Class II or greater or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation and paroxysmal supraventricular tachycardia)
History of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II?IV)
Class II or greater congestive heart failure as described in the New York Heart Association Functional Classification criteria
Cardiac function:\r\n* Known inherited coronary disease\r\n* Symptomatic heart failure (New York Heart Association [NYHA] class II-IV prior or current cardiomyopathy, or severe valvular heart disease)\r\n* Prior or current cardiomyopathy\r\n* Severe valvular heart disease\r\n* History of atrial fibrillation
History of documented congestive heart failure (CHF), New York Heart Association class II/III/IV, with a history of dyspnea, orthopnea or edema that requires current treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers or diuretics; NOTE: use of these medications for the treatment of hypertension is allowed
New York Heart Association ? Class II congestive heart failure; Clinically significant abnormality on ECG
The participant has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy,ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Criteria (Class III or IV staging)
Class II to IV heart failure as defined by the New York Heart Association functional classification system; patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction (LVEF) < 50% must be on a stable medical regimen that is optimized in the opinion of the treating physician, in consultation with a cardiologist if appropriate, to be eligible
History of symptomatic congestive heart failure of any New York Heart Association class or serious cardiac arrhythmia requiring treatment
Symptomatic congestive heart failure (New York Heart Association II-IV), unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia.
Has symptomatic congestive heart failure[New York Heart Association (NYHA) Classes III-IV], unstable angina, or cardiac arrhythmia requiring antiarrhythmic treatment
Normal left ventricular ejection fraction at baseline and no evidence of New York Heart Association class II to IV heart failure
New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
New York Heart Association (NYHA) status of less than or equal to (</=)1
New York Heart Association (NYHA) stage III/IV congestive heart failure, arrhythmias not adequately controlled, or other significant co-morbidities [e.g. active infection requiring systemic therapy, history of human immunodeficiency virus (HIV) infection, or active Hepatitis B or Hepatitis C].
Congestive heart failure of New York Heart Association (NYHA) Grade >2,
Clinically significant heart failure (New York Heart Association [NYHA] > 2), recent myocardial infarction, or symptomatic atrial fibrillation
Pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association [NYHA] grade III/IV), or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation), or subjects with a corrected QT interval (QTc) > 450 msec
Active grade III-V cardiac failure as defined by the New York Heart Association criteria
New York Heart Association stage 3 or 4 cardiac disease.
Active grade III-V cardiac failure as defined by the New York Heart Association criteria.
Active grade III-V cardiac failure as defined by the New York Heart Association criteria.
New York Heart Association stage 3 or 4 cardiac disease.
Congestive cardiac failure of > grade 2 severity according to the New York Heart Association (NYHA) defined as symptomatic at less than ordinary levels of activity
Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade >= 2)
Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade >= 2)
Cardiovascular disease resulting in New York Heart Association function status of ? 3.
Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination
Active grade III-V cardiac failure as defined by the New York Heart Association criteria
Heart failure >= New York Heart Association (NYHA) grade 3
Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
Congestive heart failure (New York Heart Association [NYHA classification])
Congestive heart failure (New York Heart Association {NYH
Congestive heart failure (New York Heart Association ? Grade 2)
New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry
History of congestive heart failure of any New York Heart Association (NYHA) criteria
Patients must not have unstable angina or New York Heart Association (NYHA) classification of congestive heart failure of grade >= 2
Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
Uncontrolled intercurrent illness including, but not limited to, the following:\r\n* Active infection\r\n* Congestive heart-failure (New York Heart Association [NYHA] grade III or IV)
Heart failure ?3 (New York Heart Association(NYHA))
History of cardiac heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment
New York Heart Association functional classification for congestive heart failure (NYHA CHF) < 3
Subjects with classification of 3 or higher heart failure as classified by the New York Heart Association (NYHA)
Patients with pre-existing cardiovascular disease (including congestive heart failure, New York Heart Association [NYHA] grade III-IV), or arrhythmia known to increase the risk or thromboembolic events (e.g., atrial fibrillation)
New York Heart Association Stage 3 or 4 cardiac disease
Congestive heart failure or New York Heart Association (NYHA) status >= 2
Congestive heart failure or New York Heart Association (NYHA) status >= 2
Congestive heart failure or New York Heart Association (NYHA) status >= 2
Congestive heart failure or New York Heart Association (NYHA) status >= 2
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure.
New York Heart Association (NYHA) grade II or greater congestive heart failure
Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure.
Left ventricular ejection fraction (LVEF) that is greater than 40%, or the absence of New York Heart Association (NYHA) classification of greater than stage II congestive heart failure
New York Heart Association class II or greater congestive heart failure
Inadequate cardiac function, as measured by left ventricular ejection fraction (LVEF) that is less than or equal to 40%, or the presence of New York Heart Association (NYHA) classification of greater than stage II congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association Grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
Patient must have no New York Heart Association (NYHA) class II or greater congestive heart failure
New York Heart Association (NYHA) Grade II or greater congestive cardiac failure.
Patients are excluded if they have New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association Grade ? II congestive heart failure.
New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
New York Heart Association (NYHA) Class II or greater congestive heart failure.
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) >= grade II or greater
Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
New York Heart Association grade II or greater congestive heart failure
Unstable angina or New York Heart Association (NYHA) grade II or greater congestive heart failure; multiple comorbidity that preclude a major abdominal surgery
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or higher congestive heart failure
New York Heart Association (NYHA) Grade III or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) Grade II or greater congestive heart failure
New York Heart Association Grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association class II or greater congestive heart failure
New York Heart Association (NYHA) Grade II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF); myocardial infarction or unstable angina within 6 months
New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
NYHA Grade II or greater congestive heart failure
New York Heart Association grade 2 or greater congestive failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) Class II or greater congestive heart failure
Have New York Heart Association class II or greater congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
Patients with a documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) grade II
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association functional classification >= 3), angina, myocardial infarction or ventricular arrhythmia.
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
Has a clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within ?180 days prior to start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment on the study
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within =<180 days prior to registration, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome =< 6 months prior to pre-randomization
Clinically significant cardiovascular disease with uncontrolled arrhythmia, New York Association class 3 or 4 congestive heart failure, history of myocardial infarction within 6 months, or prolonged corrected QT (QTc) > 500 msec
Any life-threatening illness, medical condition, or organ system dysfunction, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active autoimmune disorder, or psychiatric illness/social situations that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk; currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
Clinically significant cardiovascular disease with uncontrolled arrhythmia, New York Association class 3 or 4 congestive heart failure, history of myocardial infarction within 6 months, or prolonged corrected QT (QTc) > 500 msec
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to start of first study treatment
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association functional classification of three
Currently active clinically significant cardiovascular disease, such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease, as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months prior to first dose with study drug
Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Function Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to screening
Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Currently active, clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction, unstable angina or acute coronary syndrome within 6 months of screening
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements; currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction, unstable angina or acute coronary syndrome within 6 months prior to randomization
Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or any class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction, unstable angina or acute coronary syndrome within 6 months prior to on-study registration
Has a clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome within ?180 days prior to start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
Patients with a cardiac ejection fraction (as measured by either multi gated acquisition scan [MUGA] or echocardiogram) < 45% are excluded; currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months prior to first dose with study drug
Significant or uncontrolled intercurrent condition including, but not limited to:\r\n* Infection other than HIV, hepatitis B, or hepatitis C that is symptomatic or requires systemic treatment\r\n* Opportunistic infection within 60 days prior to enrollment\r\n* Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infection within 6 months prior to enrollment\r\n* History of stroke or intracranial hemorrhage within 6 months prior to enrollment\r\n* History of class B or class C cirrhosis, per the modified Child-Pugh classification\r\n* Psychiatric illness that would limit compliance
Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to first dose with study drug
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to enrollment
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 2 or higher congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization
NYHA classification of III or IV
STEP I: Patients should not have New York Heart Association classification III or IV heart failure or myocardial infarction within the previous 6 months
Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.
History of or current Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Appendix B).
Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV);
New York Heart Association Classification II, III, or IV
Heart failure of New York Heart Association Classification III or IV ?6 months prior to Day 1
Acute heart failure (class III or IV of the NYHA classification)
Patient with cardiac failure class III or IV of the NYHA classification
History of documented congestive heart failure (New York Heart Association functional classification III-IV);
New York Heart Association classification III or IV heart failure
New York Heart Association classification III or IV heart failure
History of documented congestive heart failure (New York Heart Association functional classification III-IV) within 6 months prior to initiation of screening
New York Heart Association (NYHA) functional classification I-II
Participants with unilateral pleural effusion will be eligible for inclusion if they fulfill the Global Initiative for Obstructive Lung Disease classification of 0-1 level for pulmonary function and New York Heart Association (NYHA) classification class 1 for cardiac function
Patients classified according to the New York Heart Association classification as having class III or IV heart disease.
Class II to IV heart failure as defined by the New York Heart Association functional classification system
NYHA classification of III or IV
In patients with symptoms of congestive heart failure, New York Heart Association (NYHA) classification of grade III or IV
have any other severe, uncontrolled medical condition, including unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification (Appendix III))
Cardiac conditions as follows: patient has a history of congestive heart failure (CHF) class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment; patient has a cardiac ejection fraction < 50% by either echocardiogram or multi-gated acquisition (MUGA) scan
New York Heart Association (NYHA) classification IIIB or IV heart failure
NYHA classification of III or IV
Has been classified according to the New York Heart Association classification as having class III or IV heart disease
Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
Symptomatic congestive heart failure (New York Heart Association classification Il-IV)
class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system;
Class III/IV cardiovascular disability according to the New York Heart Association Classification
Class III/IV cardiovascular disability according to the New York Heart Association classification
Class III/IV cardiovascular disability according to the New York Heart Association Classification
Symptoms of congestive heart failure as defined by the New York Heart Association (NYHA): Functional Classification class III or IV, or medically uncontrolled cardiac rhythm disturbance
Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Patient has a history of cardiac dysfunction including any of the following:\r\n* Myocardial infraction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction (LVEF) function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
Patients with a New York Heart Association classification of III or IV
Patient has a history of cardiac dysfunction including any of the following:\r\n* Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
NYHA class III or IV functional classification for heart failure.
Patients that have been designated Class III or IV by the New York Heart Association Functional Classification.
Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
New York Heart Association classification III or IV heart disease
Congestive heart failure (CHF), grade III or IV per New York Heart Association (NYHA) classification
New York Heart Association Functional Classification of Heart Failure: Class III or IV (Appendix 1).
New York Heart Association classification III or IV
New York Heart Association classification III or IV
New York Heart Association classification III or IV
Participants classified according to the New York Heart Association classification as having class III or IV heart disease
New York Heart Association classification III or IV
New York Heart Classification III or IV heart disease (see Appendix G).  Other severe\n             cardiovascular or cardiopulmonary disease, including COPD
Patient has a history of cardiac dysfunction including any of the following:\r\n* Myocardial infraction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function\r\n* History of or documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
Patients should not have New York Heart Association classification III or IV heart failure
Subject with Class III or IV Congestive Heart Failure as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months.
New York Heart Association Classification II, III, or IV (see APPENDIX D)
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
Class III/IV cardiovascular disability according to the New York Heart Association Classification
2. Class III or IV heart failure as defined by the New York Heart Association functional classification system up to 6 months before Cycle 1, Day 1.
Has any other severe, uncontrolled medical condition, including unstable congestive heart failure (Stage III-IV of the New York Heart Association Functional Classification) or has a known or suspected allergy to the study drug or any study drug component.
New York Heart Association classification III or IV heart failure
Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Patient has a history of cardiac dysfunction including any of the following:\r\n* Myocardial infraction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular ejection fraction (LVEF) function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
Patient has a history of cardiac dysfunction including any of the following:\r\n* Myocardial infraction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
Patients with class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system\r\n* Abnormal cardiac valve morphology (subjects with minimal abnormalities, can be entered on study with approval)
Evidence of current Class II, III, or IV heart failure as defined by the New York Heart Association [NYHA, 1994] functional classification system at the time of transition to this study.
History of cardiac dysfunction including any one of the following:\r\n* Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system at the time of transition to this study
Uncontrolled arrhythmias; any Class 3-4 cardiac diseases as defined by the New York Heart Association (NYHA) functional classification
Has decompensated congestive heart failure as defined by New York Heart Association (NYHA) functional classification III or IV
Severe cardiovascular disease; New York Heart Association (NYHA) functional classification >= 2
Patient has a history of cardiac dysfunction including any of the following:\r\n* Myocardial infraction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
Congestive heart failure ? Class 3 based on New York Heart Association Functional Classification
Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
New York Heart Association Classification III or IV
History of, or current, documented congestive heart failure (New York Heart Association functional classification III - IV), documented cardiomyopathy.
New York Heart Association classification III or IV congestive heart failure
History of any clinically significant cardiovascular disorder (i.e., symptoms above Class II per New York Heart Association [NYHA] Functional Classification);
New York Heart Association Classification III or IV
New York Heart Association Classification II, III, or IV
New York Heart Association Classification III or IV (see Appendix F)
A New York Heart Association (NYHA) classification of IV.
Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
New York Heart Association Classification III or IV (see Appendix E)
New York Heart Association classification III or IV
New York Heart Association (NYHA) classification III or IV heart failure (see Appendix G) despite medical management
History of cardiac dysfunction including any of the following:\r\n* Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function\r\n* History of documented congestive heart failure (New York Heart Association functional classification III-IV)\r\n* Documented cardiomyopathy
New York Heart Association (NYHA) classification III or IV congestive heart failure
Class II, III, or IV heart failure as defined by the New York Heart Association functional classification system.
New York Heart Association (NYHA) classification III or IV heart disease
Has Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
New York Heart Association (NYHA) classification I or II
New York Heart Association Classification III or IV heart
No current New York Heart Association classification II, III, or IV congestive heart failure
New York Heart Association classification III or IV heart failure
Patient has congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification
Class II to IV heart failure as defined by the New York Heart Association functional classification system
Congestive heart failure (New York Heart Association functional classification III-IV)
Patient with known Class III/IV congestive heart failure according to the New York Heart Association classification
History of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
History of documented congestive heart failure (New York Heart Association functional classification III-IV).
No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
New York Heart Association (NYHA) class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
Congestive heart failure (CHF) New York (NY) Heart Association class III or IV
Congestive heart failure (NYHA Class III or IV).
New York Heart Association (NYHA) class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction
Documented NYHA Class III or IV congestive heart failure,
Current congestive heart failure (New York Heart Association Class II, III or IV)
Participants with a history of congestive heart failure (New York Heart Association [NYHA] class II, III or IV) are excluded
Symptomatic congestive heart failure of New York heart Association Class III or IV
New York Heart Association (NYHA) class III or IV congestive heart failure.
New York Heart Association class III or IV heart failure
New York Heart Association Class II, III, or IV congestive heart failure
New York Heart Association Class III or IV heart failure
Participants with a history of congestive heart failure or New York Heart Association (NYHA) class III or IV functional status are excluded
Congestive heart failure of New York Heart Association class III/IV,
New York Heart Association (NYHA) Class III or IV heart failure
New York Heart Association class III or IV heart failure
Heart failure, class IV by New York Heart Association criteria
Subjects with New York Heart Association (NYHA) class III or IV heart failure.
Class II, III or IV heart failure as defined by the NYHA functional class system
Patients must have a left ventricular ejection fraction >= 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure
New York Heart Association class III or IV heart failure
New York Heart Association Class III to IV heart failure.
New York Heart Association (NYHA) Class III or IV heart failure and/or ejection fraction of < 35% as measured by echocardiogram at screening.
Absence of New York Heart Association (NYHA) class II, III, or IV congestive heart failure
Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening
New York Heart Association Class III or IV heart failure.
Uncontrolled cardiac angina or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV)
NYHA Class III or IV heart failure, or reduced LVEF <50%
History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening.
New York Heart Association (NYHA) class IV heart failure
NYHA Class III or IV heart failure
congestive heart failure (New York Heart Association class III to IV)
Subject has severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association [NYHA] class III or IV) or symptomatic ischemic heart disease
Patients with moderate to severe heart failure, New York Heart Association (NYHA) class III or IV, liver dysfunction with total bilirubin > 2.5 upper limit of normal, or serum creatinine > 2.5 mg/dL or any form of dialysis; within 30 days prior to enrollment
NYHA class IV heart failure
Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
Congestive heart failure (New York Heart Association class III or IV)
New York Heart Association class III/IV heart failure
Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
New York Heart Association class III or greater congestive heart failure
Patients with New York Heart Association (NYHA) class III or IV heart failure will be excluded
Congestive heart failure (New York Heart Association [NYHA] II, III, IV)
New York Heart Association (NYHA) Class III or IV heart failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, or other clinical signs of severe cardiac dysfunction
Documented NYHA Class III or IV congestive heart failure
Congestive heart failure New York Heart Association (NYHA) Class III or IV or history of congestive heart failure NYHA class III or IV, unless an echocardiogram or multigated acquisition scan performed within 3 months before day 1 reveals a left ventricular ejection fraction ? 45%;
Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
Patients with NYHA (New York Heart Association) class III or IV heart failure or history of a prior myocardial infarction (MI) within the last five years prior to enrollment in the study
New York Heart Association (NYHA) stage III/IV congestive heart failure, arrhythmias not adequately controlled.
History of symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV).
Congestive heart failure (New York Heart Association [NYHA] class III/IV) or left ventricular ejection fraction (LVEF) < 50% at baseline
Heart failure that meets New York Heart Association (NYHA) class III and IV definitions
Symptomatic congestive heart failure of New York Heart Association Class III or IV.
Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1.
For Cohort B:Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
Patients with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within approximately 28 days of C1D1
History of class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
Congestive heart failure (New York Heart Association class III to IV)
Class III or IV congestive heart failure per New York Heart Association
New York Heart Association (NYHA) Class III or IV congestive heart failure;
documented New York Heart Association (NYHA) Class III or IV congestive heart failure;
New York Heart Association (NYHA) class III or IV congestive heart failure
New York Heart Association (NYHA) class IV congestive heart failure
New York Heart Association (NYHA) class III or IV congestive heart failure
known autoimmune disease, known bleeding diathesis, history of congestive heart failure New York Heart Association (NYHA) class III or IV;
New York Heart Association Class III or IV heart failure;
Patients with class III or class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible
Subject has congestive heart failure classified as New York Heart Association Class IV.
Congestive heart failure New York Heart Association (NYHA) Class III or IV or history of congestive heart failure NYHA Class III or IV in the past, unless a Screening echocardiogram or multi-gated acquisition scan performed within 3 months before the Day 1 visit reveals a left ventricular ejection fraction that is ? 45%.
Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
Uncontrolled cardiac angina or symptomatic congestive heart failure (NYHA class III or IV)
Patients must have a left ventricular ejection fraction > 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure
History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration
Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), or unstable angina pectoris
Current New York Heart Association (NYHA) class II, III, or IV congestive heart failure or symptomatic heart failure within 60 days prior to the start of study drugs
Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), or unstable angina pectoris
Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
Uncontrolled congestive heart failure (NYHA II, III, IV).
Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris or congenital long QT syndrome
New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
History of uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or greater
New York Heart Association Class III or IV heart failure
Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention
Patients with congestive heart failure, class III or IV, by the New York Heart Association (NYHA) criteria
Uncontrolled malignant arrhythmias or clinical evidence of congestive heart failure (New York class IV)
Clinical evidence of significant congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV)
Subject currently has Class III or IV New York Heart Association congestive heart failure.
Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV)
Any uncontrolled congestive heart failure New York Heart Association class III or IV
Uncontrolled hypertension or congestive heart failure Class III/IV per the New York Heart Association's Heart Failure Guidelines
Class III or IV congestive heart failure by New York Heart Association
Has heart failure of Class III or IV.
Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class III or IV congestive heart failure
Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1
Has heart failure of Class III or IV
Congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease;
Congestive heart failure New York Heart Association Class III or IV, or Class II with a recent decompensation requiring hospitalization within 4 weeks before screening.
History of class III or IV congestive heart failure, as defined by the New York Heart Association
Symptomatic congestive heart failure of New York Heart Association Class III or IV
New York Heart Association class III or IV heart failure
Current or history of New York Heart Association Class III or IV heart failure.
Patients with diagnosed New York Heart Association (NYHA) class III-IV failure or documented ejection fraction (EF) < 30%
New York Heart Association class III or IV heart failure
Uncontrolled cardiac angina or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV)
Congestive Heart Failure NY Heart Association class III or IV
New York Heart Association (NYHA) class IV congestive heart failure;
Symptomatic congestive heart failure of New York heart Association Class III or IV
New York Heart Association (NYHA) class III and IV congestive heart failure
Congestive heart failure (New York Heart Association [NYHA] class III or IV)
New York Heart Association (NYHA) class III and IV congestive heart failure
Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] Class IV)
Current or history of New York Heart Association Class III or IV heart failure
Congestive heart failure (New York Heart Class III or IV).