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

NCT06424288 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2026-05-13

No results posted yet for this study

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

Interventions

DRUG

vicadrostat

vicadrostat

DRUG

empagliflozin

empagliflozin

DRUG

placebo

placebo matching vicadrostat

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-17
Primary Completion
2028-05-22
Completion
2028-05-22
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424288 on ClinicalTrials.gov