A study to test whether BI 690517 in combination with empagliflozin helps people with heart failure

A study to test whether BI 690517 in combination with empagliflozin helps people with heart failure

ClinicalTrials.gov ID: NCT06424288
Sponsor: Boehringer Ingelheim
Information provided by: Boehringer Ingelheim (Responsible Party)
Last Update Posted: 2024-11-01

Brief Summary:
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 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:

- BI 690517 and empagliflozin group: participants take BI 690517 and empagliflozin as tablets once a day.
- Placebo and empagliflozin group: participants take placebo and empagliflozin as tablets once a day.

Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.

The study does not have a fixed duration. It continues until we have enough data to see if the treatment is working.

Official 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%

Intervention / Treatment: 
- Drug: BI 690517
- Drug: Empagliflozin
- Drug: Placebo

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