A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

Exclusion Criteria

• •Acute coronary syndrome, stroke, or transient ischemic attack (TIA), coronary or peripheral revascularization procedures, valve procedures, OR any major surgical procedure within the previous 6 weeks
• •Invasive cardiac investigation and/or treatment (i.e. coronary angiography, percutaneous coronary intervention \[PCI\] or surgery) or other surgical procedure planned in the next 4 weeks
• •Use of intravenous radiographic contrast agent within 72 hours prior to screening or planned use during the study
• •Severe, in the investigators opinion, uncorrected valve disease or congenital heart disease as the cause for cardiac decompensation
• •Acute mechanical cause of decompensated heart failure such as papillary muscle rupture
• •Obstructive or infiltrative cardiomyopathy (e.g. amyloid, sarcoid, etc), suspected acute myocarditis, or heart failure related to an untreated metabolic condition (e.g. haemochromatosis)
• •Second or third degree heart block unless the subject has a ventricular pacemaker
• •Atrial fibrillation/flutter with sustained ventricular response of \>130 bpm
• •Placement of a ventricular resynchronization device within the previous 6 weeks
• •Treatment or planned treatment with intravenous inotropic agents other than digoxin at any time on this admission
• •Receipt of intravenous vasodilator therapy ≤ 6 hours prior to randomization
• •The presence of any mechanical assist device or listed for or a history of a heart transplant
• •Severe respiratory disease or anticipated need for mechanical respiratory support (i.e. mechanical ventilation)
• •Anuric in the previous 24 hours
• •Haemoglobin \<9 g/dL at screening or planned blood transfusions in the next 30 days
• •Serum potassium \>5.5 mEq/L
• •Marked proteinuria suggestive of nephrotic syndrome
• •Estimated GFR (eGFR) as per MDRD equation \<30 ml/min
• •Serum albumin of \< 2.8 g/dL
• •Liver enzymes (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) elevation \>5 times the upper limit of normal (ULN)
• •Total bilirubin \>2.0 times ULN in the absence of Gilbert's Syndrome
• •Current or planned ultrafiltration, paracentesis, haemofiltration or dialysis