HF Clinical Trials
METEORIC-HF
METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure)
Status: Complete
METEORIC-HF was a Phase 3, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical trial that evaluated the effect of treatment with omecamtiv mecarbil on exercise capacity in 276 patients with heart failure and reduced ejection fraction (HFrEF). The primary endpoint was the change in peak oxygen uptake (pVO2) on cardiopulmonary exercise testing (CPET) from baseline to Week 20.
See the results from METEORIC-HF published in The Journal of the American Medical Association
GALACTIC-HF
GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure)
Status: Complete
GALACTIC-HF was a Phase 3, double-blind, placebo-controlled, multicenter clinical trial of omecamtiv mecarbil in 8,256 patients with heart failure with reduced ejection fraction (HFrEF).
The primary composite endpoint was time to CV death or first heart failure event (heart failure hospitalization and other urgent treatment for heart failure). Secondary endpoints included time to CV death, patient reported outcomes measured by Kansas City Cardiomyopathy Questionnaire, time to first heart failure hospitalization and time to all-cause death.
See the results from GALACTIC-HF published in The New England Journal of Medicine
COSMIC-HF
COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure)
Status: Complete
COSMIC-HF was a Phase 2, double-blind, randomized, placebo-controlled, multicenter clinical trial of omecamtiv mecarbil in 448 patients with chronic heart failure and left ventricular systolic dysfunction. The primary objective was to characterize the safety, tolerability, and pharmacokinetics of omecamtiv mecarbil dosed orally during 20 weeks of treatment. Secondary objectives included change from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and NT-proBNP.
ATOMIC-AHF
ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure)
Status: Complete
ATOMIC-AHF was a Phase 2b, randomized, double-blind, placebo-controlled clinical trial evaluating the effect of an intravenous formulation of omecamtiv mecarbil in 613 patients hospitalized with acute heart failure (AHF). The primary endpoint was to evaluate the effect of 48 hours of intravenous omecamtiv mecarbil compared to placebo on dyspnea in patients with left ventricular systolic dysfunction hospitalized for AHF. The secondary objectives included the safety and tolerability of the three dose levels of omecamtiv mecarbil.
See the results from ATOMIC-AHF published in The Journal of the American College of Cardiology