Recruiting
Phase 3

Vicadrostat & Empagliflozin

Sponsor:

Boehringer Ingelheim

Code:

NCT06935370

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

vicadrostat

empagliflozin

Placebo

Study Details

Brief 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

Heart Failure

Study ID

NCT06935370

Start date

May 20, 2025

Status verified date

Sep, 2026

Completion date

Feb 22, 2029

Anticipated

Primary completion date

Feb 4, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Additional inclusion criteria apply.

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
8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.

Study Design

Enrollment

4200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: vicadrostat/empagliflozin treatment group

placebo comparator: Placebo to vicadrostat/empagliflozin treatment group

Interventions

vicadrostat

vicadrostat

empagliflozin

empagliflozin

Placebo

Placebo matching vicadrostat

Primary outcome measure

  • Time to first event of Cardiovascular (CV) death, or Hospitalisation for heart failure (HHF), or Urgent heart failure (HF) visit [ Time Frame: up to 43 months ]

Central Contacts and Locations

Central contacts

Locations

Valley Clinical Trials, Inc.

Recruiting

Covina, California, United States, 91723

Contacts

Merced Vein and Vascular Center

Recruiting

Merced, California, United States, 95340

Contacts

Radin Cardiovascular Medical Group

Recruiting

Newport Beach, California, United States, 92663

Contacts

Paradigm Clinical Research - San Diego

Recruiting

San Diego, California, United States, 92108

Contacts

Care Access Research

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Bay Area Cardiology

Recruiting

Brandon, Florida, United States, 33511

Contacts

Cardiology Associates Research Co.

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

Suncoast Research Associates, LLC

Recruiting

Doral, Florida, United States, 33172

Contacts

Malcom Randall VA Medical Center

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Velocity Clinical Research-Hallandale Beach-67888

Recruiting

Hallandale, Florida, United States, 33009

Contacts

University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

East Coast Institute For Research, LLC

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

University of Miami - Miller School of Medicine

Recruiting

Miami, Florida, United States, 33125

Contacts

Infinite Clinical Research Inc

Recruiting

Miami, Florida, United States, 33133

Contacts

Inpatient Research Clinic, LLC

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Innovation Medical Research Center

Recruiting

Palmetto Bay, Florida, United States, 33157

Contacts

Peace River Cardiovascular Center

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

St. Johns Center for Clinical Research

Recruiting

Saint Augustine, Florida, United States, 32086

Contacts

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Cardiology Partners Clinical Research Institute

Recruiting

Wellington, Florida, United States, 33449

Contacts

Cozy Research LLC

Recruiting

Wesley Chapel, Florida, United States, 33544

Contacts

Clinical Site Partners, LLC

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Atlanta Clinical Research Centers

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

NSC Research Inc

Recruiting

Johns Creek, Georgia, United States, 30024

Contacts

Chicago Medical Research

Recruiting

Hazel Crest, Illinois, United States, 60429

Contacts

Clinical Investigation Specialists, Inc.

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

AMR Park Ridge

Recruiting

Park Ridge, Illinois, United States, 60068

Contacts

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62703

Contacts

Midwest Cardiovascular Research and Education Foundation

Recruiting

Elkhart, Indiana, United States, 46514

Contacts

St. Francis Medical Group-Indiana Heart Physicians, Inc

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Cardiovascular Research of Northwest Indiana, LLC

Recruiting

Munster, Indiana, United States, 46321

Contacts

Reid Hospital

Recruiting

Richmond, Indiana, United States, 47374

Contacts

The Iowa Clinic, PC

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Kansas Nephrology Research Institute, LLC

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Robert J Dole Veterans Affairs Medical Center

Recruiting

Wichita, Kansas, United States, 67218

Contacts

West Houston Area Clinical Trial Consultants, LLC

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Heart Clinic of Hammond

Recruiting

Hammond, Louisiana, United States, 70403

Contacts

Ascension Saint Agnes Heart Care

Recruiting

Baltimore, Maryland, United States, 21229

Contacts

Metropolitan Cardiovascular Consultants

Recruiting

Beltsville, Maryland, United States, 20705

Contacts

Capitol Cardiology Associates

Recruiting

Lanham, Maryland, United States, 20706

Contacts

Cardiology and Vascular Associates - CAVA

Recruiting

Bloomfield Hills, Michigan, United States, 48304

Contacts

Henry Ford Providence Hospital

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Michigan Heart, PC

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Mayo Clinic, Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Kansas City VA Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

Contacts

St. Louis Heart and Vascular, P.C.

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Be Well Clinical Studies

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

Advanced Heart Care, LLC

Recruiting

Bridgewater, New Jersey, United States, 08807

Contacts

Mount Sinai Hospital-New York-52529

Recruiting

New York, New York, United States, 10019

Contacts

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

IMA Clinical Research Lenoir

Recruiting

Lenoir, North Carolina, United States, 28645

Contacts

Pinehurst Medical Clinic, Inc. - East

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

WakeMed

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Piedmont Healthcare, Inc.

Recruiting

Statesville, North Carolina, United States, 28625

Contacts

Wilmington Health

Recruiting

Wilmington, North Carolina, United States, 28401

Contacts

K and R Research LLC

Recruiting

Marion, Ohio, United States, 43302

Contacts

Cardiology Consultants of Philadelphia

Recruiting

Yardley, Pennsylvania, United States, 19067

Contacts

Pharmatex Research

Recruiting

Amarillo, Texas, United States, 79109

Contacts

Amarillo Heart Clinical Research Institute, Incorporated

Recruiting

Amarillo, Texas, United States, 79124

Contacts

NextStage Clinical Research

Recruiting

Beaumont, Texas, United States, 77702-1513

Contacts

Clinical Research Solution, LLC

Recruiting

Cypress, Texas, United States, 77429

Contacts

Texas Health Research and Education Institute

Recruiting

Dallas, Texas, United States, 75231

Contacts

Southwest Family Medicine Associates

Recruiting

Dallas, Texas, United States, 75235

Contacts

Helios CR Inc - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

The Methodist Hospital Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

DM Clinical Research - Irving

Recruiting

Irving, Texas, United States, 75061

Contacts

DCOL Center for Clinical Research

Recruiting

Longview, Texas, United States, 75605

Contacts

North Texas Research Associates

Recruiting

McKinney, Texas, United States, 75071

Contacts

Revival Research Institute, LLC - McKinney

Recruiting

McKinney, Texas, United States, 75071

Contacts

Texas Institute Of Cardiology

Recruiting

McKinney, Texas, United States, 75071

Contacts

Accurate Clinical Research, Inc.

Recruiting

Richmond, Texas, United States, 77469

Contacts

Baylor Scott and White Health

Recruiting

Temple, Texas, United States, 76508

Contacts

Northwest Heart Center

Recruiting

Tomball, Texas, United States, 77375

Contacts

NextStage Clinical Research

Recruiting

Waco, Texas, United States, 76712

Contacts

Carient Heart and Vascular

Recruiting

Manassas, Virginia, United States, 20109

Contacts

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Saul Vizel Medicine Professional Corporation

Recruiting

Cambridge, Ontario, Canada, N1R 7R1

Contacts

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Premier Clinical Trial Network

Recruiting

Hamilton, Ontario, Canada, L8L 5G4

Contacts

Elevate Clinical Research - KMH Hamilton

Recruiting

Kitchener, Ontario, Canada, N2M 5N4

Contacts

KMH Cardiology Centres (Mississauga)

Recruiting

Mississauga, Ontario, Canada, L5K 2L3

Contacts

Oakville Trafalgar Memorial Hospital

Recruiting

Oakville, Ontario, Canada, L6K 3W7

Contacts

James Cha, MD

Recruiting

Oshawa, Ontario, Canada, L1J 2K1

Contacts

Kawartha Cardiology Clinical Trials

Recruiting

Peterborough, Ontario, Canada, K9J 0B2

Contacts

CardioQuest Research Centre

Recruiting

Sarnia, Ontario, Canada, N7T 4P5

Contacts

Fadia El Boreky Medicine Professional Corporation

Recruiting

Waterloo, Ontario, Canada, N2J 1C4

Contacts

ViaCar Recherches Cliniques Inc. (Brossard)

Recruiting

Brossard, Quebec, Canada, J4Z 2K9

Contacts

Diex Recherche (Sherbrooke)

Recruiting

Sherbrooke, Quebec, Canada, J1L 0H8

Contacts

Diex Recherche (Trois-Rivieres)

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

Contacts

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

Recruiting

Québec, Canada, G1V 4G5

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.