Phase 2 with Elamipretide in subjects hospitalised with heart failure
Research type
Research Study
Full title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment with Elamipretide in Patients Hospitalized with Congestion due to Heart Failure
IRAS ID
199366
Contact name
Alexander Lyon
Contact email
Sponsor organisation
Stealth BioTherapeutics Inc.
Eudract number
2016-000126-19
Clinicaltrials.gov Identifier
CARD 30690, Clinical Research Network
Duration of Study in the UK
1 years, 1 months, 2 days
Research summary
Heart failure is a major cause of large economic costs, frequent hospitalisation and high levels of mortality in the Western countries. Although the management of the disease has improved, the sudden worsening of the heart condition represents a significant burden. Diuretics are the main supportive therapy to improve the signs and symptoms of heart failure. Diuretics are medicines, which help to reduce swelling and water from the body by acting on the kidney. However, diuretic treatment alone decreases in effect and does not prevent re-hospitalisation due to new episodes of heart failure.
The development of the investigational drug elamipretide (MTP-131) targets simultaneously multiple organs and could successfully improve diuretic effectiveness, kidney and cardiac function, and reduce the symptoms related to heart failure.
The purpose of the study is to evaluate the effectiveness of elamipretide compared to placebo on kidney and cardiac function and on clinical symptoms of heart failure in patients hospitalised with congestive heart failure and who required an injection of furosemide (diuretic). The safety and tolerability of elamipretide will be also evaluated.
The treatment consists of a daily injection of the study drug or placebo for up to 7 days.
The study could last approximately a year. In total 366 subjects will participate in the study around the world including approximately 65 from the UK.
REC name
London - Harrow Research Ethics Committee
REC reference
16/LO/1386
Date of REC Opinion
3 Nov 2016
REC opinion
Further Information Favourable Opinion