COMET-HF
Research type
Research Study
Full title
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
IRAS ID
1011618
Contact name
Truc Moyer
Contact email
Sponsor organisation
Cytokinetics Inc.
Eudract number
2024-519219-32
Clinicaltrials.gov Identifier
Research summary
This study is about heart failure with reduced ejection fraction (HFrEF). Ejection fraction is a measure of how well the heart pumps blood. In people with HFrEF, the ejection fraction is lower than normal, meaning the heart is not pumping blood out to the body as well as it should to meet the body's needs. People with HFrEF often have shortness of breath, chest pain, swelling, weakness, and fatigue. HFrEF puts people at a higher risk for other serious medical problems like stroke, very abnormal heartbeat (arrythmia), cardiac arrest (heart stopping), and potential death. People with HFrEF may also need more hospitalisations. Current treatments that try to make the heart squeeze harder (called calcitropes) are not always effective and can cause side effects or may not work for some patients. Therefore, there is a need to find other medicines for the treatment of HFrEF. Omecamtiv mecarbil is believed to work by helping to increase the heart’s ability to pump blood, but potentially in a safe way. Omecamtiv mecarbil is considered experimental and has not yet been approved for treating people with HFrEF.
The main purpose of this study is to find how well omecamtiv mecarbil works to treat heart failure in participants with HFrEF. To check this, the study doctors will measure the occurrence of heart failure-related events including hospitalisations, heart failure-related deaths, heart transplant, and stroke in heart failure patients with reduced ejection fraction. The other purposes of this study are to find out if omecamtiv mecarbil reduces the risk of heart failure-related events and strokes in patients with HFrEF and to see how safe omecamtiv mecarbil is by monitoring the number and seriousness of side effects in participants. To understand how well omecamtiv mecarbil works, it will be compared with a placebo.
REC name
Wales REC 5
REC reference
25/WA/0054
Date of REC Opinion
18 Mar 2025
REC opinion
Further Information Favourable Opinion