- A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure — Recruiting • Phase III • Cardiology / Cardiovascular • NCT06424288.
- This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study….
- Sponsor: Boehringer Ingelheim.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once…
- : 1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information 4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2 5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.