NCT06424288

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

EASi-HF Preserved - 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 Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,000 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 a day. * Placebo/empagliflozin group: participants take placebo/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 there is enough data to see if the treatment is working.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	vicadrostat	vicadrostat
DRUG	empagliflozin	empagliflozin
DRUG	placebo	placebo matching vicadrostat

Timeline

• Start date: 2024-06-17
• Primary completion: 2028-05-22
• Completion: 2028-05-22
• First posted: 2024-05-22
• Last updated: 2026-04-15

Locations

653 sites across 30 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Romania, Saudi Arabia, Serbia, Slovenia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study