EASi-HF reduced
Research type
Research Study
Full title
EASi-HF reduced – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with symptomatic chronic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) < 40%
IRAS ID
1011708
Contact name
Hasan Daoud
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Research summary
Heart failure (HF) is a condition in which the heart does not pump sufficient blood around the body. Despite recent treatment advances in the management of HF, the risk of impaired quality of life, hospitalisation for HF and even death remains substantial in patients with HF. This clinical research trial proposes a treatment option for people with HF who have a heart that isn’t pumping enough blood around the body. The proposed treatment is a combination of a medication being investigated (vicadrostat) with a medication already being used for HF, empagliflozin (empa). Vicadrostat is designed to stop the body from producing a hormone that, at increased levels, can cause high blood pressure and other health issues. This trial aims to find out if the combination of vicadrostat and empa is effective and safe for people with HF who are already receiving the best available treatment. The trial will also look at whether vicadrostat and empa are more effective than using placebo (dummy medication) and empa in addition to best available treatment. Before joining the trial, potential participants will undergo tests to confirm that they are eligible. This period will last up to 3 weeks. Afterwards, eligible participants will be randomly assigned to either vicadrostat and empa or placebo and empa. Trial participants will take their study tablets once a day for between 1 to 3.5 years. Participants will be expected to visit the hospital at least 6 times for assessments and have at least 2 phone calls with a member of the research team. When participants stop taking the trial medication or the trial is to end, they will attend the hospital for one final
visit. After this, a 1-2 week follow-up period will occur that will include 1 follow-up visit at the hospital.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
25/NW/0126
Date of REC Opinion
10 Jun 2025
REC opinion
Further Information Favourable Opinion