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NCT06935370

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

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

4200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-20

Study Completion Date

2029-02-22

Brief Summary

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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 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 1 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. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, must go to hospital due to heart failure, or die during the study. The time until these events are observed is compared between the treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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vicadrostat/empagliflozin treatment group

Group Type EXPERIMENTAL

vicadrostat

Intervention Type DRUG

vicadrostat

empagliflozin

Intervention Type DRUG

Placebo

Placebo matching vicadrostat

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (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 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 protocol.
4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \< 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).
5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory
6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local/international guidelines and judgement of the investigator.

Exclusion Criteria

1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.
2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.
3. Receiving the following treatments:

* A direct renin inhibitor (e.g. aliskiren) at Visit 2
* More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2
* Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
* Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
* In case of acute decompensated HF:

* i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation
* i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)
4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)
5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

U1111-1317-0692

Identifier Type: OTHER

Identifier Source: secondary_id

1378-0018

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

vicadrostat/empagliflozin treatment group

vicadrostat

empagliflozin

Placebo to vicadrostat/empagliflozin treatment group

empagliflozin

Placebo

Interventions

vicadrostat

empagliflozin

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boehringer Ingelheim

Responsible Party

Locations

University of Alabama at Birmingham

Alliance for Multispecialty Research, LLC

Drug Research and Analysis Corporation

Ram Dandillaya, MD, Inc.

Valley Clinical Trials, Inc.

North Coast Cardiology

Orange County Research Center

Merced Vein and Vascular Center

Radin Cardiovascular Medical Group

Amicis Research Center

Paradigm Clinical Research - San Diego

Care Access Research

Bridgeport Hospital

Bay Area Cardiology

Cardiology Associates Research Co.

Suncoast Research Associates, LLC

Malcom Randall VA Medical Center

Velocity Clinical Research-Hallandale Beach-67888

University of Florida

East Coast Institute For Research, LLC

First Coast Cardiovascular Institute

Jacksonville Center for Clinical Research

University of Miami - Miller School of Medicine

Central Therapy Center, Inc.

Inpatient Research Clinic, LLC

Innovation Medical Research Center

Peace River Cardiovascular Center

St. Johns Center for Clinical Research

Cardiology Partners Clinical Research Institute

Cardiology Partners Clinical Research Institute

Cozy Research LLC

Clinical Site Partners, LLC

Atlanta Clinical Research Centers

Columbus Regional Research Institute

NSC Research Inc

Northwest Heart Clinical Research, LLC

Illinois Masonic Hospital

Chicago Medical Research

Clinical Investigation Specialists, Inc.

AMR Park Ridge

Springfield Clinic

Midwest Cardiovascular Research and Education Foundation

St. Francis Medical Group-Indiana Heart Physicians, Inc

Indiana Medical Research Institute

Cardiovascular Research of Northwest Indiana, LLC

Reid Hospital

The Iowa Clinic, PC

University of Kansas Medical Center

Kansas Nephrology Research Institute, LLC

Robert J Dole Veterans Affairs Medical Center

West Houston Area Clinical Trial Consultants, LLC

Norton Healtcare - Norton Heart and Vascular Institute

Heart Clinic of Hammond

Grace Research, LLC-Shreveport-64616

Ascension Saint Agnes Heart Care