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

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, diuresis, dropsy, congestion, elamipretide, MTP-131, Bendavia™ Read More

Inclusion Criteria:

• A history of chronic heart failure for at least 1 month
• Treated with ≥40 mg/day of furosemide or bumetanide ≥1 mg/day or torasemide ≥10 mg/day for at least 1 month
• In-hospital observation/admission and treatment for ≤72 hours and primary cause for admission is heart failure with persistent congestion in the opinion of the Investigator (i.e. at least +2 pitting oedema and/or an estimated 8 kg gain in weight over baseline over the past 4 weeks) requiring intravenous loop diuretic therapy
• Sufficiently severe oedema to justify treatment by an intravenous infusion of furosemide of 10 mg/hour for at least 48 hours
• Systolic blood pressure >90 mmHg and considered to be haemodynamically stable, in the opinion of the Investigator
• History of left ventricular ejection fraction (LVEF) ≤40% confirmed in the last 18 months
• NT-proBNP >1500 pg/ml or BNP >500 pg/ml
• An eGFR of >30 mL/min/1.73 m2 using the eGFR (mL/min/1.73 m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African American)

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