[c09aa8]: / clusters / 3009knumclusters / clust_299.txt

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New York Heart Association > Grade 2 congestive heart failure within 6 months prior to study entry, unless asymptomatic and well controlled with medication
History of congestive heart failure
STEP I: Patients should not have New York Heart Association classification III or IV heart failure or myocardial infarction within the previous 6 months
No congestive heart failure (CHF) within 182 days of registration
No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.
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
Symptomatic congestive heart failure (NYHA class ? II);
New York Heart Association (NYHA) class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure)
Congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
Congestive heart failure (CHF) New York (NY) Heart Association class III or IV
New York Heart Association (NYHA) grade II or greater congestive heart failure.
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
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
New York Heart Association Class II-IV congestive heart failure
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).
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 757
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)
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
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,
Patients who have congestive heart failure (New York Heart Association [NYHA] class III or IV), sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block within the six months preceding enrollment
Patients with QTc interval > 450 msecs or other factors that increase the risk of QTc prolongation or arrhythmic events (ex. heart failure, clinically significant hypokalemia, clinically significant hypomagnesemia, family history of long QT syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
Current congestive heart failure (New York Heart Association Class II, III or IV)
Heart failure of New York Heart Association Classification III or IV ?6 months prior to Day 1
New York Heart Association (NYHA) Class II or higher congestive heart failure.
New York Heart Association (NYHA) stage III/IV congestive heart failure, arrhythmias not adequately controlled, active infections, or other significant co-morbidities [e.g. active central nervous system metastases and/or carcinomatous meningitis, active infection requiring systemic therapy, history of human immunodeficiency virus (HIV) infection, or active Hepatitis B or Hepatitis C.
New York Heart Association heart failure class >= 3
Clinically significant cardiac disease (New York [NY] Heart Association class III or IV), including chronic arrhythmia, or pulmonary disease
Participants with a history of congestive heart failure (New York Heart Association [NYHA] class II, III or IV) are excluded
Acute heart failure (class III or IV of the NYHA classification)
Patient with cardiac failure class III or IV of the NYHA classification
Symptomatic congestive heart failure of New York heart Association Class III or IV
Active angina pectoris or NY Heart Association Class III-IV
New York Heart Association (NYHA) class III or IV congestive heart failure.
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].
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
History of documented congestive heart failure (New York Heart Association functional classification III-IV);
New York Heart Association class III or IV heart failure
New York Heart Association classification III or IV heart failure
New York Heart Association classification III or IV heart failure
Diagnosis of symptomatic congestive heart failure (New York Heart Association [NYHA] II-IV) or symptomatic or poorly controlled cardiac arrhythmia
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)
History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea).
Patients with QTc interval > 450 msecs or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) including heart failure that meets New York Heart Association (NYHA) class III and IV definitions are excluded
New York Heart Association Class II, III, or IV congestive heart failure
New York Heart Association Class III or IV heart failure
History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea)
Any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
Participants with a history of congestive heart failure or New York Heart Association (NYHA) class III or IV functional status are excluded
TREATMENT EXCLUSION: Symptomatic cardiac disease (New York Heart Association [NYHA] class III or IV disease)
History of documented congestive heart failure (New York Heart Association functional classification III-IV) within 6 months prior to initiation of screening
Adequate cardiac function (?New York Heart Association [NYHA] Class II).
Symptomatic congestive heart failure
New York Heart Association (NYHA) functional classification I-II
Congestive heart failure of New York Heart Association (NYHA) Grade >2,
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
Clinically significant heart failure (New York Heart Association [NYHA] > 2), recent myocardial infarction, or symptomatic atrial fibrillation
Congestive heart failure of New York Heart Association class III/IV,
Patients classified according to the New York Heart Association classification as having class III or IV heart disease.
Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within four months prior to enrollment
New York Heart Association (NYHA) Class III or IV heart failure
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)
New York Heart Association class III or IV heart failure
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
Cardiovascular disability status of New York Heart Association Class greater than or equal to 3.
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
congestive heart failure > class II NYHA,
Uncontrolled coronary disease or New York Heart Association (NYHA) class III-IV heart disease
Heart failure, class IV by New York Heart Association criteria
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
Subjects with New York Heart Association (NYHA) class III or IV heart failure.
Active grade III-V cardiac failure as defined by the New York Heart Association criteria
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
New York Heart Association (NYHA) grade II or greater congestive heart failure
Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:\r\n* New York Heart Association heart failure > class 2\r\n* Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia
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
Class II to IV heart failure as defined by the New York Heart Association functional classification system
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.
A cardiovascular disability status of New York Heart Association class >= 2
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
Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of enrollment.
Class II, III or IV heart failure as defined by the NYHA functional class system
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.
Patients must have a left ventricular ejection fraction >= 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure
Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure.
New York Heart Association stage 3 or 4 cardiac disease.
New York Heart Association class III or IV heart failure
Not eligible for more intensive cytotoxic chemotherapy or consolidative autologous stem cell transplant based on one or more of the following:\r\n* Clinically significant heart or lung comorbidities, as reflected by at least 1 of the following:\r\n** Left ventricular ejection fraction (LVEF) =< 50%\r\n** Chronic stable angina or congestive heart failure controlled with medication\r\n** New York Heart Association (NYHA) class III or IV heart failure\r\n** Symptomatic chronic pulmonary disease or requirement for intermittent or continuous oxygen therapy\r\n* Presence of other medical comorbidity or limitation in functional status which the investigator judges to be incompatible with an acceptable risk to the subject with the use of intensive chemotherapy; the associated comorbidity or functional limitation must be clearly documented in the medical record at the time of enrollment OR
Cardiac failure New York Heart Association (NYHA) III or IV Crohn’s disease or ulcerative colitis
Symptomatic congestive heart failure (New York Heart Association class >= 2) within the 6 months prior to study drug administration
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
Active grade III-V cardiac failure as defined by the New York Heart Association criteria.
New York Heart Association Class III to IV heart failure.
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 (NYHA) Class III or IV heart failure and/or ejection fraction of < 35% as measured by echocardiogram at screening.
In patients with symptoms of congestive heart failure, New York Heart Association (NYHA) classification of grade III or IV
Current symptomatic congestive heart failure or history of symptomatic congestive heart failure in the preceding 3 months, defined as New York (NY) Heart Association classification 2- 4
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))
Absence of New York Heart Association (NYHA) class II, III, or IV congestive heart failure
Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose
New York Heart Association (NYHA) class III or IV heart disease
Active grade III-V cardiac failure as defined by the New York Heart Association criteria.
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)
Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status; history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
Patients with history of congestive heart failure stage III or greater
Participant has cardiovascular disability status of New York Heart Association Class >
New York Heart Association stage 3 or 4 cardiac disease.
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
Patients with any of the following cardiac conditions:\r\n* Symptomatic restrictive cardiomyopathy\r\n* Unstable angina within 4 months prior to enrollment\r\n* New York Heart Association functional class III-IV heart failure on active treatment\r\n* Symptomatic pericardial effusion
New York Heart Association (NYHA) classification IIIB or IV 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)
A cardiovascular disability status of New York Heart Association class >= 2
Has been classified according to the New York Heart Association classification as having 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)
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
NYHA Class III or IV heart failure, or reduced LVEF <50%
Patients with history of congestive heart failure stage III or greater
Ineligible to receive cisplatin-based neoadjuvant chemotherapy based upon at least one of the following criteria:\r\n* Creatinine clearance < 60 ml/min \r\n* Eastern Cooperative Oncology Group (ECOG) performance status = 2\r\n* Grade ? 2 hearing loss \r\n* Grade ? 2 neuropathy\r\n* New York Heart Association class III heart failure
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
Have New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of recent (within 6 months) myocardial infarction or sustained (> 30 seconds) ventricular tachyarrhythmias
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.
History of myocardial infarction (MI) or New York Heart Association (NYHA) Class II-IV congestive heart failure within 6 months of the administration of the first dose of ARQ 751 (MI occurring > 6 months of the first dose of ARQ 751 will be permitted); Grade 2 or worse conduction defect (e.g., right or left bundle branch block)
Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade >= 2)
History of New York Heart Association class 3-4 congestive heart failure or patients with history myocardial infarction within 6 months of starting study treatment
New York Heart Association (NYHA) cardiac class 3-4 heart disease
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
Symptomatic congestive heart failure (New York Heart Association classification Il-IV)
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
class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system;
Congestive heart failure requiring treatment (New York Heart Association [NYHA] grade >= 2)
NYHA Class III or IV heart failure
Class III/IV cardiovascular disability according to the New York Heart Association Classification
Congestive heart failure > New York Heart Association (NYHA) class 2
Congestive heart failure > New York Heart Association (NYHA) class 2
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
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.
Subjects must not have New York Heart Association (NYHA) class III or IV heart failure, unstable angina, or a history of recent (within 6 months) myocardial infarction or sustained (> 30 seconds) ventricular tachyarrhythmias
Symptomatic heart failure NYHA Class ? 3
congestive heart failure (New York Heart Association class III to IV)
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
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
History of myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of ARQ 092 (MI that occurred > 6 months prior to the first dose of ARQ 092 will be permitted)
Congestive heart failure (CHF) NYHA Class ? 3, or
Symptomatic congestive heart failure
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
Documented New York Heart Association (NYHA) class I, II and III
NYHA class IV heart failure
Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure (New York Heart Association class III and IV)
Congestive heart failure New York Heart Association (NYHA) class III or worse (marked limitation of physical activity; comfortable at rest; less than ordinary activity causes fatigue, palpitation, or dyspnea)
Cardiovascular disease resulting in New York Heart Association function status of ? 3.
Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention
Clinically significant heart disease, defined as New York Heart Association (NYH) class III or IV
Patients with history of congestive heart failure are excluded
Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines (Appendix D).
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
Patients with any of the following cardiac conditions:\r\n* Symptomatic restrictive cardiomyopathy\r\n* Unstable angina within 4 months prior to enrollment\r\n* New York Heart Association functional class III-IV heart failure on active treatment\r\n* Symptomatic pericardial effusion
Severe cardiac insufficiency (New York Heart Association [NYHA] III or IV), with uncontrolled and/or unstable cardiac or coronary artery disease
Patients with a New York Heart Association classification of III or IV
Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4) (Appendix B).
New York Heart Association (NYHA) grade II or greater congestive heart failure
NYHA class III or IV functional classification for heart failure.
Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination
NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
Have clinical symptomatic congestive heart failure defined at >= Class II of the New York Heart Association functional classification system or LVEF < 50% at baseline.
Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia or conduction abnormalities uncontrolled by conventional interventions; myocardial infarction within 6 months of study entry
New York Heart Association (NYHA) grade II or greater congestive heart failure
Patients must not have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
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
Congestive heart failure (New York Heart Association class III or IV)
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%
New York Heart Association class III/IV heart failure
New York Heart Association class 3-4 heart failure
Congestive heart failure (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months
Patients with clinically significant heart disease (NYHA Class III or IV).
Conditions which would increase risk of lactic acidosis including:\r\n* Known alcoholism or ingestion of more than 3 alcoholic beverages per day\r\n* History of congestive heart failure defined as New York Heart Association (NYHA) class III or IV\r\n* History of metabolic acidosis\r\n* Ongoing or active infection concerning for sepsis or systemic inflammatory response syndrome (SIRS)
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
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
New York Heart Association (NYHA) cardiac class 3-4 heart disease
Patients with New York Heart Association (NYHA) class III or IV heart failure will be excluded
Active grade III-V cardiac failure as defined by the New York Heart Association criteria
Congestive heart failure New York Heart Association (NYHA) class 3 or 4
Symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia; symptomatic heart failure (New York Heart Association [NYHA] class II-IV)
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association [NYHA] grade ? 2), uncontrolled hypertension or clinically significant arrhythmia currently requiring medical treatment
Subjects must not have conditions associated with increased risk of metformin-associated lactic acidosis, including New York Heart Association class III or IV congestive heart failure, history of acidosis of any type, alcoholic liver disease, or habitual intake of 3 or more alcoholic beverages per day
EXCLUSION CRITERIA FOR REGISTRATION: subjects must not have conditions associated with increased risk of metformin-associated lactic acidosis, including New York Heart Association class III or IV congestive heart failure, history of acidosis of any type, alcoholic liver disease, or habitual intake of 3 or more alcoholic beverages per day
No acute congestive heart failure
Patient with active heart disease (New York Heart Association [NYHA] class >= 3 as assessed by history and physical examination)
New York Heart Association (NYHA) grade II or greater congestive heart failure
Uncontrolled coronary disease or New York Heart Association (NYHA) class III-IV heart disease
History of significant cardiac disease, particularly uncompensated congestive heart failure New York Heart Association (NYHA) grade 2 or more or left ventricular ejection fraction (LVEF) < 40% on any prior assessment; (assessment of LVEF prior to therapy is not required in the absence of other clinical indicators of heart disease); patients with a prior LVEF < 40% will require-evaluation prior to study entry
New York Heart Association classification III or IV heart disease
Current clinical heart failure or symptomatic ischemic heart disease
Congestive heart failure (New York Heart Association [NYHA] II, III, IV)
Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2
Heart failure > New York Heart Association (NYHA) class II
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.
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).
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
Clinically stable in New York heart association (NYHA) class 2 or 3 for the 3 months preceding screening Inclusion Criteria for Group 2
Congestive heart failure (CHF), grade III or IV per New York Heart Association (NYHA) classification
Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia requiring treatment
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.
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
Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion
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.
New York Heart Association Functional Classification of Heart Failure: Class III or IV (Appendix 1).
Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions
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
Part 2: history of have severe cardiac disease (New York Heart Association functional class III or IV)
New York Heart Association (NYHA) stage III/IV congestive heart failure, arrhythmias not adequately controlled.
Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) grade III or IV heart failure.
Active ischemic heart disease or congestive heart failure
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
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
Evidence of New York Heart Association (NYHA) functional class III or IV heart disease
History of symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV).
New York Heart Association class III or IV cardiac disease or myocardial infarction within the past 12 months
New York Heart Association classification III or IV
Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
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
New York Heart Association Grade II or greater congestive heart failure
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
Congestive heart failure of any severity (New York Heart Association [NYHA] class I-IV)
Adequate cardiac functions assessed by 2 dimensional (D) echocardiography (ECHO).\r\n* (New York Heart Association [NYHA] cardiac III-IV excluded).
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
Symptomatic congestive heart failure (CHF)
Congestive heart failure (New York Heart Association [NYHA] class III/IV) or left ventricular ejection fraction (LVEF) < 50% at baseline
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
Heart failure >= New York Heart Association (NYHA) grade 3
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
Patients must not have ejection fraction decrease > 10% from baseline (as determined by ECHO) or other ejection fraction decrease accompanied by other clinical signs/symptoms of New York Heart Association (NYHA) class III or IV heart failure, measured within 28 days prior to registration; if any question exists regarding individual patient eligibility in this situation, contact the study chair for determination
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.
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
Previous history of congestive heart failure
New York Heart Association (NYHA) class II or higher congestive heart failure
New York Heart Association (NYHA) grade II or greater 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%.
Grade III/IV congestive heart failure, as defined by New York Heart Association (NYHA) criteria, or myocardial infarction within 6 months
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.
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.
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
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
Patient must have no New York Heart Association (NYHA) class II or greater congestive heart failure
Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure
Subject has unstable angina, a significant cardiac arrhythmia, or New York Heart Association Class 3 or 4 congestive heart failure.
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
History of class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
Congestive cardiac failure of >= Grade 3 severity according to New York Heart Association (NYHA) functional classification defined as subjects with marked limitation of activity and who are comfortable only at rest.
New York Heart Association (NYHA) class II or higher congestive heart failure
Evidence of New York Heart Association (NYHA) functional class III or IV heart disease
Congestive heart failure (New York Heart Association class III to IV)
Any condition associated with increased risk of metformin-associated lactic acidosis; (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
New York Heart Association (NYHA) Grade II or greater congestive cardiac failure.
History of myocardial infarction and unstable angina within 6 months before study drug treatment; symptomatic congestive heart failure (Congestive Heart Failure New York Heart Association Class III or IV); congenital long QT syndrome; or ventricular arrhythmias defined as grade ?2 according to NCI CTCAE, v4
Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure.
Class III or IV congestive heart failure per New York Heart Association
New York Heart Association (NYHA) Class III or IV congestive heart failure;
Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II)
Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure
Patients are excluded if they have New York Heart Association (NYHA) grade II or greater congestive heart failure
documented New York Heart Association (NYHA) Class III or IV congestive heart failure;
No congestive heart failure < 6 months
No New York Heart Association Class > II congestive heart failure
New York Heart Association (NYHA) class III or IV congestive heart failure
New York Heart Association Grade ? II congestive heart failure.
New York Heart Association Classification II, III, or IV (see APPENDIX D)
New York Heart Association (NYHA) class IV congestive heart failure
New York Heart Association (NYHA) class III or IV 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)
known autoimmune disease, known bleeding diathesis, history of congestive heart failure New York Heart Association (NYHA) class III or IV;
have congestive heart failure or poorly controlled cardiac arrhythmia per New York Heart Association Class II-IV heart disease
New York Heart Association Class III or IV heart failure;
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
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
Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
Class III/IV cardiovascular disability according to the New York Heart Association Classification
New York Heart Association (NYHA) Class II or greater congestive heart failure.
Known active symptomatic congestive heart failure
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
Congestive heart failure (New York Heart Association [NYHA classification])
History or evidence of current ?Class II congestive heart failure as defined by New York Heart Association.
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
Patients with cardiovascular disease including congestive heart failure grade III or IV according to the New York Heart Association (NYHA) classification, left ventricular ejection fraction of < 50%, myocardial infarction within previous 6 months or poorly controlled hypertension
Patients with symptoms of congestive heart failure are not eligible
Clinically significant cardiac disease (New York Heart Association, class III or IV)
Patients must not have New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Patients with New York Heart Association Class II or greater congestive heart failure (Class II is defined as symptoms of fatigue, dyspnea or other symptoms with ordinary physical activity)
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
Congestive heart failure (New York Heart Association {NYH
Subject has congestive heart failure classified as New York Heart Association Class IV.
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
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.
New York Heart Association (NYHA) grade II or greater congestive heart failure
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
Symptomatic congestive heart failure
Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure, New York Heart Association (NYHA) class III or IV
Subjects who have a history or current evidence of uncontrolled cardiovascular disease i.e. NYHA (New York Heart Association) Class III or 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%.
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.
The participant has symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
New York Heart Association classification III or IV heart failure
New York Heart Association (NYHA) Class II or higher 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 (NYHA) >= grade II or greater
Active congestive heart failure (New York Heart Association [NYHA] Class III or IV, refer to Appendix F), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, acute diffuse infiltrative pulmonary disease, pericardial disease, or myocardial infarction within 6 months prior to enrollment
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])
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)
Uncontrolled cardiac angina or symptomatic congestive heart failure (NYHA class III or IV)
Congestive heart failure, defined as New York Heart Association (NYHA) Class II, within 3 months before C1D1 (see Appendix 1).
Participant has a cardiovascular disability status of New York Heart Association Class greater than 2.
Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type, intake of 3 or more alcoholic beverages per day on average over the past 6 months)
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
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%
Congestive heart failure (New York Heart Association ? Grade 2)
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
Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
Any history of unstable angina, myocardial infarction, New York Heart Association (NYHA) class III or IV heart failure, and/or pulmonary hypertension
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 (NYHA) grade II or greater congestive heart failure
Patients with significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within six months of study entry, uncontrolled dysrhythmias, or QTc greater than or equal to 450 msec
New York Heart Association >/= Grade 3 congestive heart failure within 6 months prior to study entry
History of Class III or IV congestive heart failure, as defined by the New York Heart Association Classification of Congestive Heart Failure
Symptomatic congestive heart failure
New York Heart Association class III or IV cardiovascular disease
History of congestive heart failure (CHF)
Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months before first dose
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
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%.
Has symptomatic congestive heart failure (CHF)
New York Heart Association Class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition, or hypertensive or metabolic condition
Patients with any of the following cardiac conditions:\r\n* Restrictive cardiomyopathy\r\n* Unstable angina within 6 months prior to enrollment\r\n* New York Heart Association functional class III-IV heart failure \r\n* Symptomatic pericardial effusion
History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; or history of known cardiac arrhythmias unless it has been stably controlled
No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration
New York(NY) Heart Association Class III or IV cardiac disease or Myocardial infarction within the past 12 months.
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
Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association Class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months).
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
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
History of congestive heart failure of any New York Heart Association (NYHA) criteria
History of myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association classification within 6 months of the first dose of ARQ 087 (MI occurring >6 months of the first dose of ARQ 087 will be permitted)
Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), or unstable angina pectoris
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)
New York Heart Association (NYHA) Grade II or greater congestive heart failure.
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)
New York Heart Association grade II or greater congestive heart failure
Active congestive heart failure (New York Heart Association [NYHA] class II-IV)
Patient has any condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
Patients must not have unstable angina or New York Heart Association (NYHA) classification of congestive heart failure of grade >= 2
No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease
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
Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
Evidence of New York Heart Association (NYHA) functional class III or IV heart disease
Moderate or severe heart disease based on New York Heart Association (NYHA) criteria
Uncontrolled congestive heart failure (NYHA II, III, IV).
Unstable angina or New York Heart Association (NYHA) grade II or greater congestive heart failure; multiple comorbidity that preclude a major abdominal surgery
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)
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.
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
New York Heart Association (NYHA) grade II or greater congestive heart failure
History of uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or greater
Uncompensated congestive heart failure
New York Heart Association (NYHA) grade II or higher congestive heart failure
New York Heart Association Class III or IV heart failure
New York Heart Association (NYHA) Grade III or greater congestive heart failure
Class II, III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
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
Clinically significant cardiac disease (New York [NY] Heart Association class III or IV), including chronic arrhythmias, or pulmonary disease
Grade 2 or greater congestive heart failure
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 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)
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)
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
Patients with New York Heart Association class 3 or 4 disease
New York Heart Association (NYHA) grade II or greater congestive heart failure
New York Heart Association (NYHA) Grade II or greater congestive heart failure
Myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of ARQ 087 (MI that occurred > 6 months prior to the first dose of ARQ 087 will be permitted)
Uncontrolled arrhythmias; any Class 3-4 cardiac diseases as defined by the New York Heart Association (NYHA) functional classification
New York Heart Association Class III or IV cardiac disease, including preexisting clinically significant ventricular arrhythmia, congestive heart failure, or cardiomyopathy
Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
a. Class I and above myocardial ischemia or myocardial infarction, cardiac arrhythmia and Class 2 or above congestive heart failure classified according to New York Heart Association (NYHA)
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%
History of hospitalization for Congestive Heart Failure
Uncontrolled malignant arrhythmias or clinical evidence of congestive heart failure (New York class IV)
New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review
Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.
Clinical evidence of significant congestive heart failure (CHF) (New York Heart Association [NYHA] Class III or IV)
Has decompensated congestive heart failure as defined by New York Heart Association (NYHA) functional classification III or IV
Clinically significant cardiac disease (New York [NY] Heart Association class III or IV) or pulmonary disease
Patients with any class of New York Heart Association (NYHA) CHF or heart failure with preserved ejection fraction (HFPEF)
Subject currently has Class III or IV New York Heart Association congestive heart failure.
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.
No prior history of:\r\n* Congestive heart failure (New York Heart Association [NYHA] class I to IV)\r\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency
History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure (New York Heart Failure [NYHA] class III or IV congestive heart failure) within 6 months prior to study enrollment or left ventricular ejection fraction (LVEF) < 50%
New York Heart Association (NYHA) class III or IV heart disease
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%;
Unstable angina, myocardial infarction or New York Heart Association (NYHA) class III/IV congestive heart failure within 30 days preceding study enrollment
Severe cardiovascular disease; New York Heart Association (NYHA) functional classification >= 2
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
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
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
New York Heart Association Grade II or greater congestive heart failure
Abnormal cardiac function as manifested by 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
Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV)
Patient with active heart disease (New York Heart Association [NYHA] class greater than or equal to 2 as assessed by history and physical examination)
Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: myocardial infarction and the New York Heart Association (NYHA) class III or IV heart failure
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)
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
New York Heart Association (NYHA) grade II or greater congestive heart failure
Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure
Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease
Class II-IV New York Heart Association (NYHA) congestive heart failure
Has a medical history of symptomatic Congestive Heart Failure (CHF) (NYHA classes II-IV) or serious cardiac arrhythmia.
New York Heart Association class II or greater congestive heart failure
Class III or IV congestive heart failure by New York Heart Association
congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.
Congestive heart failure ? Class 3 based on New York Heart Association Functional Classification
Clinically significant cardiac disease (New York Heart Association class III/IV) or severe debilitating pulmonary disease
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)
Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Symptomatic congestive heart failure
New York Heart Association Classification III or IV
Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association [NYHA] class III or IV), active angina pectoris or myocardial infarction within 6 months
History of, or current, documented congestive heart failure (New York Heart Association functional classification III - IV), documented cardiomyopathy.
Have congestive heart failure (CHF) New York Heart Association class ?3 or symptomatic or poorly controlled cardiac arrhythmia.
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 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);
Congestive heart failure.
History of congestive heart failure;
Has heart failure of Class III or IV.
Patients with history of congestive heart failure
New York Heart Association Classification III or IV
Symptomatic congestive heart failure
History of congestive heart failure (CHF)
New York Heart Association (NYHA) Grade II or greater congestive heart failure
New York Heart Association Classification II, III, or IV
Unstable angina, significant cardiac arrhythmia, or New York Heart Association (NYHA) class III or IV congestive heart failure
Condition associated with increased risk of metformin-associated lactic acidosis:\r\n* New York Heart Association class III or IV heart failure\r\n* Intake of 3 or more alcoholic beverages per day\r\n* Known history of lactic acidosis
Active symptomatic congestive heart failure
New York Heart Association (NYHA) congestive heart failure (CHF) class II or better
Current congestive heart failure (New York Heart Association Class II-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
Congestive heart failure > Class II New York Heart Association Functional Classification, current pericarditis, myocardial infarction within 6 months, or symptomatic coronary artery disease.
Has heart failure of Class III or 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)
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.
A history or evidence of current >=Class II congestive heart failure as defined by the New York Heart Association (NYHA) guidelines
New York Heart Association Classification III or IV (see Appendix F)
Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
DONOR: History of severe cardiovascular disease, defined as New York Heart Association class III or IV
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%
A New York Heart Association (NYHA) classification of IV.
Congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to prior to C1D1 for Phase 1b or prior to randomization for Phase 2
Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
History of class III or IV congestive heart failure, as defined by the New York Heart Association
New York Heart Association Classification III or IV (see Appendix E)
New York Heart Association (NYHA) class III or IV; NOTE: patients classified as NYHA class II controlled with treatment may participate, with increased monitoring
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)
Active congestive heart failure (New York Heart Association [NYHA] class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention; myocardial infarction within 6 months
History of cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II
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)
Congestive heart failure (CHF) currently requiring therapy
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
Symptomatic congestive heart failure;
History of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II?IV)
Symptomatic congestive heart failure of New York Heart Association Class III or IV
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
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)
Congestive heart failure (CHF) currently requiring therapy
Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria.
New York Heart Association class III or IV heart failure
Heart failure ?3 (New York Heart Association(NYHA))
Class II or greater congestive heart failure as described in the New York Heart Association Functional Classification criteria
Congestive heart failure (CHF) (New York Heart Association class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction in the previous six months
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%
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
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
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
New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.
Patients with New York Heart Association (NYHA) class II-IV heart failure
NYHA Grade II or greater congestive heart failure
New York Heart Association grade 2 or greater congestive failure
New York Heart Association (NYHA) classification III or IV congestive heart failure
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
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
Cardiac failure, New York Heart Association (NYHA) Class II according to the NYHA Functional Classification,
The participant has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure.
History of cardiac heart failure of any New York Heart Association criteria or serious cardiac arrhythmia requiring treatment
New York Heart Association (NYHA) grade II or greater 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) Class II or greater congestive heart failure
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.
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)
Clinically significant heart disease (New York Heart Association [NYHA] class III or IV) within six months
New York Heart Association functional classification for congestive heart failure (NYHA CHF) < 3
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
Subject currently has Class 3 or 4 New York Heart Association congestive heart failure.
New York Heart Association (NYHA) classification I or II
Active symptomatic congestive heart failure
History of symptomatic congestive heart failure of any New York Heart Association class or serious cardiac arrhythmia requiring treatment
New York Heart Association Classification III or IV heart
History of congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4;
No current New York Heart Association classification II, III, or IV congestive heart failure
Uncontrolled heart failure as defined by New York Heart Association (NYHA) class 3 or 4
Have New York Heart Association class II or greater congestive heart failure
Unstable cardiovascular function:\r\n* Symptomatic ischemia\r\n* Congestive heart failure New York Heart Association (NYHA) class > 3\r\n* Myocardial infarction (MI) within 3 months
Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:\r\n* A left-ventricular ejection fraction < 50%\r\n* Myocardial infarction within 2 years of randomization\r\n* New York Heart Association (NYHA) class III or IV heart failure
Clinically significant cardiac disease defined by congestive heart failure New York Heart Association (NYHA) Class 3 or Class 4.
Current or history of New York Heart Association Class III or IV heart failure.
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
Patients with history of congestive heart failure
Patients with diagnosed New York Heart Association (NYHA) class III-IV failure or documented ejection fraction (EF) < 30%
Severe cardiac disease (New York Heart Association functional class III or IV) or coronary artery disease
New York Heart Association class III or IV heart failure
Congestive heart failure
Congestive heart failure
Receiving treatment for cardiomyopathy or congestive heart failure
New York Heart Association (NYHA) grade II or greater congestive heart failure
History of congestive heart failure; systolic heart failure defined as ejection fraction (EF) =< 40%, or diastolic heart failure defined as EF > 40% PLUS systemic manifestation of heart failure
Congestive heart failure (CHF)
Patients with history of congestive heart failure
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV)
New York Heart Association classification III or IV heart failure
History of New York Heart Association Class 3 or 4 heart failure;
Symptomatic congestive heart failure (New York Heart Association II-IV), unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia.
Uncontrolled cardiac angina or symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV)
Have with history of severe cardiac disease (New York Heart Association functional class III or IV)
Patients with any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association class III or IV functional status, history of acidosis of any type)
Subjects with classification of 3 or higher heart failure as classified by the New York Heart Association (NYHA)
Congestive heart failure refractory to medical management
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)
NYHA stage 3 or 4 congestive heart failure
Congestive Heart Failure NY Heart Association class III or IV
Patients with any of the following cardiac conditions:\r\n* Symptomatic restrictive cardiomyopathy\r\n* Dilated cardiomyopathy\r\n* Unstable angina within 4 months prior to enrollment\r\n* New York Heart Association functional class III-IV heart failure on active treatment\r\n* Symptomatic pericardial effusion
Severe cardiac disease (New York Heart Association class III or greater)
Patient has congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification
Patients with a documented history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) grade II
Class II to IV heart failure as defined by the New York Heart Association functional classification system
New York Heart Association (NYHA) class IV congestive heart failure;
No condition associated with increased risk of metformin-associated lactic acidosis (e.g. congestive heart failure defined as New York Heart Association [NYHA] class III or IV functional status, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
Congestive heart failure
Liver impairment or congestive heart failure
Symptomatic congestive heart failure of New York heart Association Class III or IV
congestive heart failure
New York Heart Association Stage 3 or 4 cardiac disease
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 (NYHA) class III and IV congestive heart failure
Patients with class II heart failure or worse, per New York Heart Association (NYHA) classification
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 (New York Heart Association [NYHA] class III or IV)
New York Heart Association (NYHA) class III and IV congestive heart failure
Congestive heart failure (New York Heart Association functional classification III-IV)
Has symptomatic congestive heart failure[New York Heart Association (NYHA) Classes III-IV], unstable angina, or cardiac arrhythmia requiring antiarrhythmic treatment
Congestive heart failure of New York Heart Association Class ? 3 or known left ventricular ejection fraction < 40%, or
Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] Class IV)
Congestive heart failure or New York Heart Association (NYHA) status >= 2
Patient with known Class III/IV congestive heart failure according to the New York Heart Association classification
History of congestive heart failure
New York Heart Association class III/IV cardiac disease
Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months)
Normal left ventricular ejection fraction at baseline and no evidence of New York Heart Association class II to IV heart failure
Heart rate > 100
Patients with history of congestive heart failure
Confirmed left ventricular ejection fraction ?50% or any cardiac insufficiency > New York Heart Association (NYHA) class II currently or within the past 6 months,
Symptomatic congestive heart failure.
Patients may not have New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) < 50%; patients with a corrected QT (QTc) > 470 ms, a family history of long QT syndrome, and those on medications known to cause Torsades de Pointes will be excluded from the study
Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV) (PCS study)
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.
Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment
Active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention or myocardial infarction within the protocol-specified period prior to enrollment
Active congestive heart failure (NYHA Class III-IV) ischemia, conduction abnormalities
Current or history of New York Heart Association Class III or IV heart failure
Congestive heart failure (New York Heart Class III or IV).
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).