Study of Omecamtiv Mecarbil in Patients with Chronic Heart Failure
Research type
Research Study
Full title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction
IRAS ID
215706
Contact name
Craig Barr
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2016-002299-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 5 days
Research summary
The purpose of this study is to find out more about how an investigational study drug called omecamtiv mecarbil, works in people with heart failure. Omecamtiv mecarbil is an investigational medicine that increases the heart’s ability to pump and is also known as AMG 423.
People who may be eligible to participate in this study have heart failure, which means that the heart cannot pump blood as well as normal. They are already taking medicines that help with heart failure. However, even with treatment, heart failure can make people feel unwell with symptoms like shortness of breath or swelling. People with heart failure also sometimes need to go to the hospital for treatment, and may not live as long as people without heart failure. This study will help find out if taking omecamtiv mecarbil can make people with heart failure feel better, have to go to the hospital less often, or live longer. It is expected that when added to standard of care, omecamtiv mecarbil will be well tolerated and superior to placebo in reducing the risks of cardiovascular death or heart failure events.
Omecamtiv mecarbil will be compared to placebo (a pill that does not contain active ingredients) and should be taken orally twice a day. Patients will need to come to the hospital for study visits. The study includes electrocardiograms (ECGs) at different timepoints. An ECG is a recording of the normal electrical activity of the heart. Blood will be collected and patient questionnaires will be taken.
It is estimated that enrollment into the study will take approximately 2 years. It is also estimated that the study will end approximately 2 years after the last participants start the study.
The study will be conducted in several hospitals in the United Kingdom, as well as in other countries (global study).
REC name
East Midlands - Derby Research Ethics Committee
REC reference
17/EM/0005
Date of REC Opinion
15 Feb 2017
REC opinion
Further Information Favourable Opinion