Safety and Efficacy Study of Istaroxime in Acute Decompensated Heart Failure Patients

Exclusion Criteria

• •Positive pregnancy test in females of childbearing potential;
• •Systolic blood pressure \< 85 mmHg or \> 120 mmHg;
• •Oral treatment with digoxin within one week before current hospitalization;
• •Any inotrope administered during the current hospitalization
• •Presence of cardiogenic shock or its occurrence within the past month;
• •Acute coronary syndrome within the past 3 months;
• •Coronary artery bypass graft or percutaneous coronary intervention within the past month;
• •Stroke within the past 6 months;
• •Atrial fibrillation with uncontrolled HR (HR \> 100 beats per minute (bpm);
• •Life threatening ventricular arrhythmia or ICD (implantable cardioverter defibrillator) shock within the past month;
• •Presence of a CRT (cardiac resynchronization therapy), ICD or pacemaker devices implanted within the past month;
• •Second or third degree atrio-ventricular block without pacemaker;
• •Abnormal safety lab values obtained within the last 24 hours of the screening period prior to pulmonary arterial catheter (PAC) insertion
• •Any inotrope administered during the current hospitalization period
• •Heart rate \> 120 bpm or \< 50 bpm;
• •cTnI \> 0.5 ng/mL or cTnI \> ULN and \> 1.25x the first screening assessment