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NCT06935370 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
A Phase 3 study of Heart Failure, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 4,200
- Enrollment target
- 20
- Study locations
NCT06935370: Recruiting Phase 3 study of Heart Failure, sponsored by Boehringer Ingelheim.
NCT06935370 is a Phase 3 study of Heart Failure that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 4,200 participants, above the 2,038-participant average among 397 other Heart Failure trials with a reported enrollment target (106% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06935370, a Phase 3 study of Heart Failure, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 4,200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG vicadrostat
- DRUG empagliflozin
Study Locations (20)
California
- Cure Clinical Research - Beverly Hills
- Valley Clinical Trials, Inc. - Covina
- North Coast Cardiology - Encinitas
- Orange County Research Center - Lake Forest
- Merced Vein and Vascular Center - Merced
- Radin Cardiovascular Medical Group - Newport Beach
- Amicis Research Center - Nordhoff - Northridge
- University of California San Diego - San Diego
- Paradigm Clinical Research - San Diego - San Diego
- Amicis Research Corporate - Santa Clarita
- Care Access Research - Thousand Oaks
Florida
- Bay Area Cardiology - Brandon
- Cardiology Associates Research Co. - Daytona Beach
- Suncoast Research Associates, LLC - Doral
- Malcom Randall VA Medical Center - Gainesville
- Velocity Clinical Research-Hallandale Beach-67888 - Hallandale
Alabama
- University of Alabama at Birmingham - Birmingham
- Alliance for Multispecialty Research, LLC - Mobile
- Drug Research and Analysis Corporation - Montgomery
Connecticut
- Bridgeport Hospital - Bridgeport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,200 participants |
| Start Date | 2025-05-20 |
| Est. Completion | 2029-02-22 |
| Phase | Phase 3 |
What NCT06935370 shows while recruiting
NCT06935370 is an interventional study that assigns participants to a tested intervention. Its 4,200 participants enrollment target places it among the larger protocols in the corpus, above the 2,038-participant average among 397 other Heart Failure trials with a reported enrollment target (106% higher).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06935370 names 20 study sites across 4 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06935370 about?
NCT06935370 is a clinical study titled "A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart". This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out...
What is the current status of trial NCT06935370?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 4,200 participants. The study started on 2025-05-20. Estimated completion is 2029-02-22.
What conditions does trial NCT06935370 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT06935370?
The interventions under investigation include: Placebo (DRUG), vicadrostat (DRUG), empagliflozin (DRUG).
Who is sponsoring clinical trial NCT06935370?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06935370 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06935370's enrollment target sits among peer trials
4,200 26th of 397 higher than 372 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
RECRUITING · Phase 3
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