EASi-HF
Research type
Research Study
Full title
EASi-HF – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral BI 690517 and empagliflozin compared with placebo and empagliflozin in participants with symptomatic heart failure (HF: NYHA II-IV) and left ventricular ejection fraction (LVEF) ≥40%
IRAS ID
1010216
Contact name
Iris Deis
Contact email
Sponsor organisation
Boehringer Ingelheim International GmbH
Clinicaltrials.gov Identifier
Research summary
Globally, heart failure (HF) affects an estimated 64 million people and is the leading cause of deaths worldwide. There is currently no cure for HF, but medications and lifestyle changes can be prescribed to help manage symptoms. An unmet need for effective HF therapies remains, especially for chronic HF with left ventricular ejection fraction (LVEF) of 40% or higher. LVEF is the measure of how well the left ventricle is pumping out blood around the body per contraction. This clinical research trial considers a proposed treatment option for people with chronic heart failure (HF) who have LVEF of ≥40%. The proposed treatment is a combination of an investigational medication (BI 690517) with an approved medication for HF, empagliflozin (empa). BI 690517 is an aldosterone Synthase inhibitor class of drug designed to stop the body from producing the hormone aldosterone, which at increased levels can cause high blood pressure, chronic kidney disease, or HF. Empa is an approved medication used to prevent HF amongst other things. This trial will find out if BI 690517 + empa is effective and safe for people with HF and LVEF of ≥40%, who are already receiving the best standard-of-care (SoC). The trial will also look at whether BI 690517 + empa is more effective than using placebo (looks like BI 690517 but does not contain any actives) + empa in addition to SoC. The screening period will last ≤3 weeks, after which eligible participants will be randomly assigned either: BI 690517 + empa or placebo + empa. During the treatment period, participants will take their assigned medication orally once a day for about 1.5-3.5 years. Participants will visit the trial site at least 9 times for trial assessments and have 6 phone calls with a member of the site staff. When participants stop taking the trial medication or the trial is to end, they will attend an end of treatment visit. After this, a 1-2 week follow-up period will occur that will include 1 follow-up visit at the trial site.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0485
Date of REC Opinion
19 Aug 2024
REC opinion
Further Information Favourable Opinion