Patients with other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) that meets New York Heart Association (NYHA) class II or above
History of familial long QT syndrome, or use of medications that may cause QTc interval prolongation
Congenital long QT syndrome
Any of the following related to risk of torsades de pointes and sudden cardiac death:* History of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), torsades de pointes, or resuscitated cardiac arrest unless currently addressed with an implanted cardiac defibrillator* Concomitant treatment with an anti-arrhythmic agent to prevent or control arrhythmia; agents used for rate-control of atrial fibrillation are permitted provided that they are not prohibited due to potential drug interactions* Known congenital long QT syndrome* Second degree atrioventricular (AV) block type II, third degree AV block, or ventricular rate < 50 bpm or > 120 bpm
Congenital long QT syndrome or family history of long QT syndrome
Significant active cardiovascular or pulmonary disease including:* Uncontrolled hypertension (i.e., systolic blood pressure > 180 mmHg, diastolic blood pressure > 95 mmHg); use of anti-hypertensive agents to control hypertension before cycle 1 day 1 is allowed* Pulmonary hypertension* Uncontrolled asthma or oxygen (O2) saturation < 90% by arterial blood gas analysis or pulse oximetry on room air* Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement* History of arrhythmia requiring an implantable cardiac defibrillator* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) e.g. medically significant (symptomatic) bradycardia, complete left bundle branch block, third degree heart block and second-degree heart block or history of arrhythmia requiring an implantable cardiac defibrillator; or within the last 6 months before administration of the first dose of drug:** Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)** Placement of a pacemaker for control of rhythm** Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures** Ischemic cerebrovascular event, including transient ischemic attack and artery revascularization procedures** New York Heart Association (NYHA) class III or IV heart failure** Pulmonary embolism* Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTcF >= 470 msec (mean value) obtained from 3 ECGs, using the screening clinic ECG machine derived QTc value, or history of congenital long QT syndrome, or torsades de pointes); any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval* Left ventricular ejection fraction (LVEF) by either multigated acquisition (MUGA) or echocardiography (ECHO) less than lower limit of normal
Any of the following cardiac criteria:* Mean resting corrected QT interval (QTc using Fredericas formula [QTcF]) > 470 msec* Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block)* Congenital long QT syndrome or family history of long QT syndrome
Cardiac disease that would preclude the use of any of the drugs included in the GI002 treatment regimen; this includes but is not limited to:* Clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling temporary pacemaker* Ventricular tachycardia or supraventricular tachycardia that requires treatment with class Ia antiarrhythmic drugs (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmic drug (e.g., sotalol, amiodarone, dofetilide); use of other antiarrhythmic drugs is permitted* Second- or third-degree atrioventricular (AV) block unless treated with a permanent pacemaker* Complete left bundle branch block (LBBB)* History of long QT syndrome* Corrected QT (QTc) >= 450ms
Known cardiac disorder, including:* Uncontrolled hypertension (blood pressure [BP] of >= 150/95 despite medical support/management)* Acute coronary syndrome within 6 months prior to starting treatment* Uncontrolled angina  Canadian Cardiovascular Society grade II-IV despite medical support/management* Heart failure New York Heart Association (NYHA) class II or above* Prior or current cardiomyopathy including but not limited to the following:** Known hypertrophic cardiomyopathy* Known arrhythmogenic right ventricular cardiomyopathy* Baseline left ventricular ejection fraction (LVEF) =< 55%* Previous moderate or severe impairment of left ventricular systolic function (LVEF < 45% on echocardiography or equivalent on multi-gated acquisition scan [MUGA])even if full recovery has occurred* Severe valvular heart disease* Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiography (ECG) at rest* Fridericia's correction formula (QTcF) interval > 450 msec 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) are excluded; the use of medication(s) that can prolong corrected QT (QTc) interval is prohibited while treated on this study
Patients with the following cardiac conditions are excluded:* Uncontrolled hypertension (adults: blood pressure [BP] of >= 150/95 despite medical support/management; participants 18 years of age and younger should have a blood pressure =< 95th percentile for age, height and gender; preexisting hypertension in adults should be controlled [either with pharmacological or non-pharmacological methods] at the time of enrollment)* Acute coronary syndrome within 6 months prior to starting treatment* Uncontrolled angina  Canadian Cardiovascular Society grade II-IV despite medical support/management* Heart failure New York Heart Association (NYHA) class II or above* Prior or current cardiomyopathy including but not limited to the following:** Known hypertrophic cardiomyopathy* Known arrhythmogenic right ventricular cardiomyopathy* Baseline left ventricular ejection fraction (LVEF) =< 55%* Previous moderate or severe impairment of left ventricular systolic function (LVEF < 50% on echocardiography or equivalent on Multi-Gated Acquisition Scan [MUGA]) even if full recovery has occurred* Severe valvular heart disease* Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest* QT interval corrected according to Fridericias formula (QTcF) interval > 450 msec 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) are excluded.; the use of medication(s) that can prolong QTc interval is prohibited while treated on this study
No history of congenital prolonged corrected QT (QTc) syndrome, New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)
Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
Any of the following cardiac criteria:* Mean resting corrected QT interval (Fridericia's correction formula [QTcF]) > 470 ms ms obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived corrected QT (QTc) value* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
Significant cardiac disease or abnormality, including any one of the following:* Left ventricular ejection fraction < 50% at screening (assessed by echocardiography, cardiac MRI or multigated acquisition [MUGA])* Corrected QT Fridericia's correction formula (QTcF) > 470 ms on screening electrocardiogram (ECG), or a clinically-relevant ECG abnormality* Congenital long QT syndrome* History of sustained ventricular tachycardia, ventricular fibrillation, or torsades de pointes* Presence of atrial fibrillation with tachyarrhythmia (ventricular response rate > 100 beats per minute [bpm])* Bradycardia (heart rate < 50 bpm)* Complete left bundle branch block* Bifascicular block (complete right bundle branch block and anterior or posterior left hemiblock)* Myocardial infarction, acute coronary syndrome (including unstable angina), coronary revascularization procedures, or coronary arterial bypass grafting within the 6 months prior to starting study drug* Cardiac troponin (either troponin T or troponin I) > ULN* Congestive heart failure of New York Heart Association class III or IV* Unstable angina pectoris