A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)

NCT06736574 Phase 3 RECRUITING

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.

Details

Lead sponsor	Cytokinetics
Phase	Phase 3
Status	RECRUITING
Enrolment	1800
Start date	2024-12-19
Completion	2027-12

Conditions

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Interventions

• Omecamtiv Mecarbil (OM)
• Placebo

Primary outcomes

• Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke — From randomization to the first event of CV death or HF event, whichever occurs first, assessed until the last patient exits the study, estimated to last about 3 years
  Efficacy of omecamtiv mecarbil compared with placebo on the risk of HF outcomes in patients with symptomatic HFrEF and severely reduced ejection fraction in the setting of guideline-directed medical therapy per local standard of care.

Countries

United States, Canada, France, Germany, Greece, Italy, Poland, Spain, United Kingdom