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RecruitingPhase 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

Boehringer Ingelheim · NCT06935370

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
4200
US sites recruiting
79
Study start
May 20, 2025
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: vicadrostat; empagliflozin; Placebo

Conditions: Heart Failure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria

  • At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years
  • 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
  • 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.
  • 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)).
  • Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory
  • 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.

Additional inclusion criteria apply.

Exclusion criteria

  • 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.
  • 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.
  • 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)
  • 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)
  • Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2
  • Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
  • 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
  • Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.

Recruiting US locations

  • Valley Clinical Trials, Inc.

    Covina, CA 91723

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Merced Vein and Vascular Center

    Merced, CA 95340

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Radin Cardiovascular Medical Group

    Newport Beach, CA 92663

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Paradigm Clinical Research - San Diego

    San Diego, CA 92108

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Care Access Research

    Thousand Oaks, CA 91360

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Bay Area Cardiology

    Brandon, FL 33511

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cardiology Associates Research Co.

    Daytona Beach, FL 32117

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Suncoast Research Associates, LLC

    Doral, FL 33172

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Malcom Randall VA Medical Center

    Gainesville, FL 32608

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Velocity Clinical Research-Hallandale Beach-67888

    Hallandale, FL 33009

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • University of Florida

    Jacksonville, FL 32209

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • East Coast Institute For Research, LLC

    Jacksonville, FL 32216

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Jacksonville Center for Clinical Research

    Jacksonville, FL 32216

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • University of Miami - Miller School of Medicine

    Miami, FL 33125

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Infinite Clinical Research Inc

    Miami, FL 33133

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Inpatient Research Clinic, LLC

    Miami Lakes, FL 33014

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Innovation Medical Research Center

    Palmetto Bay, FL 33157

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Peace River Cardiovascular Center

    Port Charlotte, FL 33952

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • St. Johns Center for Clinical Research

    Saint Augustine, FL 32086

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • University of South Florida

    Tampa, FL 33606

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cardiology Partners Clinical Research Institute

    Wellington, FL 33449

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cozy Research LLC

    Wesley Chapel, FL 33544

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Flourish Research

    Winter Park, FL 32789

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Atlanta Clinical Research Centers

    Atlanta, GA 30342

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • NSC Research Inc

    Johns Creek, GA 30024

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Chicago Medical Research

    Hazel Crest, IL 60429

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Clinical Investigation Specialists, Inc.

    Libertyville, IL 60048

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • AMR Park Ridge

    Park Ridge, IL 60068

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Springfield Clinic

    Springfield, IL 62703

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Midwest Cardiovascular Research and Education Foundation

    Elkhart, IN 46514

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • St. Francis Medical Group-Indiana Heart Physicians, Inc

    Indianapolis, IN 46237

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Indiana Medical Research Institute

    Merrillville, IN 46410

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, IN 46321

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Reid Hospital

    Richmond, IN 47374

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • The Iowa Clinic, PC

    West Des Moines, IA 50266

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Kansas Nephrology Research Institute, LLC

    Wichita, KS 67214

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Robert J Dole Veterans Affairs Medical Center

    Wichita, KS 67218

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • West Houston Area Clinical Trial Consultants, LLC - Wichita

    Wichita, KS 67226

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Heart Clinic of Hammond

    Hammond, LA 70403

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Ascension Saint Agnes Heart Care

    Baltimore, MD 21229

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Metropolitan Cardiovascular Consultants

    Beltsville, MD 20705

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Capitol Cardiology Associates

    Lanham, MD 20706

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Cardiology and Vascular Associates - CAVA

    Bloomfield Hills, MI 48304

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Henry Ford Providence Hospital

    Southfield, MI 48075

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Michigan Heart, PC

    Ypsilanti, MI 48197

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Minneapolis VA Health Care System

    Minneapolis, MN 55417

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Mayo Clinic, Rochester

    Rochester, MN 55905

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Regions Hospital

    Saint Paul, MN 55101

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Kansas City VA Medical Center

    Kansas City, MO 64128

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • St. Louis Heart and Vascular, P.C.

    St Louis, MO 63136

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Be Well Clinical Studies

    Omaha, NE 68144

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Advanced Heart Care, LLC

    Bridgewater, NJ 08807

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Mount Sinai Hospital-New York-52529

    New York, NY 10019

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Icahn School of Medicine at Mount Sinai

    New York, NY 10029

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • IMA Clinical Research Lenoir

    Lenoir, NC 28645

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Pinehurst Medical Clinic, Inc. - East

    Pinehurst, NC 28374

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Piedmont Healthcare, Inc.

    Statesville, NC 28625

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • Wilmington Health

    Wilmington, NC 28401

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • VA Northeast Ohio Healthcare System

    Cleveland, OH 44106

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

  • K and R Research LLC

    Marion, OH 43302

    Site contact: Boehringer Ingelheim · 833-602-2368 · unitedstates@bitrialsupport.com

+ 19 more on the official record.

Study contacts (from the official record)

  • Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
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