Effects of Elamipretide on Left Ventricular Function in Patients With Heart Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial

Butler J, Khan MS, Anker SD, et al. · Journal of Cardiac Failure

Neither dose changed left-ventricular end-systolic volume versus placebo (4 mg: difference −0.3 mL, p = 0.90; 40 mg: +2.3 mL, p = 0.28) or any secondary endpoint. The only randomized human data at a 4 mg/day dose, and it produced no efficacy signal while being well tolerated over 4 weeks.

Population

71 adults with stable heart failure and reduced ejection fraction

Intervention

Elamipretide 4 mg or 40 mg subcutaneous daily for 28 days

Comparator

Placebo

Limitations

Four weeks only; cardiac imaging endpoints; sponsor employee among authors; baseline imbalances (the 4 mg arm started with the largest ventricles).