Recruiting
Phase 3

Vicadrostat & Empagliflozin

Sponsor:

Boehringer Ingelheim

Code:

NCT06424288

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 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

Heart Failure

Study ID

NCT06424288

Start date

Jun 17, 2024

Status verified date

Aug, 2026

Completion date

May 22, 2028

Anticipated

Primary completion date

May 22, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
2. Signed and dated written informed consent in accordance with 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 International Conference on Harmonisation (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 participant information
4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:

1. in participants with body mass index (BMI) <27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
2. in participants with BMI ≥27 kg/m² to <35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
3. in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
7. At least one of the following:

  • Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1
  • Documented hospitalisation for HF within 6 months prior to Visit 1
  • Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1

  • in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
  • for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
  • Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1
8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply.

Exclusion criteria:

1. Treatment with an mineralocorticoid receptor antagonist (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 MRA should not be interrupted with the intention of enrolment into the study
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
  • 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 (Visit 2)
  • 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)
  • Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
  • Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, 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, coronary artery bypass graft surgery/CABG)
5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) 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 genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.

Study Design

Enrollment

6000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: vicadrostat/empagliflozin

placebo comparator: placebo/empagliflozin

Interventions

vicadrostat

vicadrostat

empagliflozin

empagliflozin

placebo

placebo matching vicadrostat

Primary outcome measure

  • Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit [ Time Frame: up to 42 months ]

Central Contacts and Locations

Central contacts

Locations

Diagnostic and Medical Clinic

Recruiting

Mobile, Alabama, United States, 36604

Contacts

Mobile Heart Specialists, PC

Recruiting

Mobile, Alabama, United States, 36608

Contacts

Velocity Clinical Research-Chula Vista

Recruiting

Chula Vista, California, United States, 91911

Contacts

University of California Irvine

Recruiting

Orange, California, United States, 92868

Contacts

North America Research Institute

Recruiting

San Dimas, California, United States, 91773

Contacts

Amicis Research Center - Valencia

Recruiting

Santa Clarita, California, United States, 91355

Contacts

Orange County Research Center

Recruiting

Tustin, California, United States, 92780

Contacts

Bridgeport Hospital

Recruiting

Bridgeport, Connecticut, United States, 06610

Contacts

Excel Medical Clinical Trials

Recruiting

Boca Raton, Florida, United States, 33434

Contacts

Bay Area Cardiology

Recruiting

Brandon, Florida, United States, 33511

Contacts

Clearwater Cardiovascular and Interventional Consultants

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Cardiology Associates Research Co.

Recruiting

Daytona Beach, Florida, United States, 32117

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 Health Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

East Coast Institute for Research, LLC - Jacksonville

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

First Coast Cardiovascular Institute

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Clearwater Cardiovascular Consultants-Largo-69917

Recruiting

Largo, Florida, United States, 33777

Contacts

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Sacred Heart Medical Specialty Group

Recruiting

Miramar Beach, Florida, United States, 32550

Contacts

Southwest Florida Research, LLC

Recruiting

Naples, Florida, United States, 34102

Contacts

Ocala Cardiovascular Research

Recruiting

Ocala, Florida, United States, 34471

Contacts

Ocala Research Institute, Inc

Recruiting

Ocala, Florida, United States, 34471

Contacts

Charlotte Cardiovascular Institute, PA

Recruiting

Port Charlotte, Florida, United States, 33952

Contacts

East Coast Institute for Research, LLC-Saint Augustine-63032

Recruiting

Saint Augustine, Florida, United States, 32086

Contacts

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

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

Columbus Regional Research Institute

Recruiting

Columbus, Georgia, United States, 31904

Contacts

NSC Research Inc

Recruiting

Johns Creek, Georgia, United States, 30024

Contacts

Kootenai Medical Center

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Northwest Heart Clinical Research, LLC

Recruiting

Arlington Heights, Illinois, United States, 60005

Contacts

Illinois Masonic Hospital

Recruiting

Chicago, Illinois, United States, 60657

Contacts

Chicago Medical Research

Recruiting

Hazel Crest, Illinois, United States, 60429

Contacts

Clinical Investigation Specialists, Inc.-Libertyville-69941

Recruiting

Libertyville, Illinois, United States, 60048

Contacts

AMR Park Ridge

Recruiting

Park Ridge, Illinois, United States, 60068

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

Indiana Medical Research Institute

Recruiting

Merrillville, Indiana, United States, 46410

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

West Houston Area Clinical Trial Consultants, LLC

Recruiting

Wichita, Kansas, United States, 67226

Contacts

Norton Heart Specialists

Recruiting

Louisville, Kentucky, United States, 40205

Contacts

Grace Research, LLC-Bossier City-51040

Recruiting

Bossier City, Louisiana, United States, 71111

Contacts

Heart Clinic of Hammond

Recruiting

Hammond, Louisiana, United States, 70403

Contacts

Grace Research, LLC-Shreveport-64616

Recruiting

Shreveport, Louisiana, United States, 71105

Contacts

Louisiana Heart Center - Slidell

Recruiting

Slidell, Louisiana, United States, 70458

Contacts

Ascension Saint Agnes Heart Care

Recruiting

Baltimore, Maryland, United States, 21229

Contacts

AMR Dearborn

Recruiting

Dearborn, Michigan, United States, 48126

Contacts

Sparrow Clinical Research Institute

Recruiting

Lansing, Michigan, United States, 48910-0826

Contacts

Henry Ford Providence Hospital

Recruiting

Southfield, Michigan, United States, 48075

Contacts

Trinity Health Michigan D/B/A Michigan Heart

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Minneapolis VA Health Care System

Recruiting

Minneapolis, Minnesota, United States, 55417

Contacts

Jackson Heart Clinic, P.A.

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

North Kansas City Hospital

Recruiting

North Kansas City, Missouri, United States, 64116

Contacts

St. Louis Heart and Vascular, P.C.

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Velocity Clinical Research-Lincoln-69943

Recruiting

Lincoln, Nebraska, United States, 68506

Contacts

Advanced Heart Care, LLC

Recruiting

Bridgewater, New Jersey, United States, 08807

Contacts

Garden State Heart Care, PC

Recruiting

Manalapan, New Jersey, United States, 07726

Contacts

Cardio Metabolic Institute

Recruiting

Somerset, New Jersey, United States, 08873

Contacts

NYU Langone Health

Recruiting

New York, New York, United States, 10001

Contacts

Mount Sinai Hospital-New York-52529

Recruiting

New York, New York, United States, 10029

Contacts

Cardiac Care and Vascular Medicine, PLLC

Recruiting

The Bronx, New York, United States, 10469

Contacts

Medication Management, LLC

Recruiting

Greensboro, North Carolina, United States, 27405

Contacts

WakeMed

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

K and R Research LLC

Recruiting

Marion, Ohio, United States, 43302

Contacts

Mercy Health St. Vincent Medical Center

Recruiting

Toledo, Ohio, United States, 43608

Contacts

Bon Secours Medical Group Greenville Specialty Care, LLC

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Monument Health

Recruiting

Rapid City, South Dakota, United States, 57701

Contacts

Helios CR Inc

Recruiting

Jackson, Tennessee, United States, 38305

Contacts

East Coast Institute For Research LLC

Recruiting

Jefferson City, Tennessee, United States, 37760

Contacts

Pharmatex Research

Recruiting

Amarillo, Texas, United States, 79109

Contacts

Amarillo Heart Clinical Research Institute, Incorporated

Recruiting

Amarillo, Texas, United States, 79124

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

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Helios CR Inc

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Private Practice Leadership, LLC

Recruiting

Katy, Texas, United States, 77493

Contacts

Texas Cardiology Research Center PLLC

Recruiting

Kingwood, Texas, United States, 77339

Contacts

DCOL Center for Clinical Research

Recruiting

Longview, Texas, United States, 75605

Contacts

North Texas Research Associates

Recruiting

McKinney, Texas, United States, 75071

Contacts

Texas Institute Of Cardiology

Recruiting

McKinney, Texas, United States, 75071

Contacts

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Carient Heart and Vascular

Recruiting

Manassas, Virginia, United States, 20109

Contacts

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Selma Medical Associates, Winchester

Recruiting

Winchester, Virginia, United States, 22601

Contacts

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Drug Research and Analysis Corporation

Recruiting

Madison, Wisconsin, United States, 53717

Contacts

ProHealth Care Research Institute and Cardiology Associates

Recruiting

Waukesha, Wisconsin, United States, 53188

Contacts

Cambridge Cardiac Care Centre

Recruiting

Cambridge, Ontario, Canada, N1R 6V6

Contacts

Curnew Medicine Professional Corporation

Recruiting

Hamilton, Ontario, Canada, L8L 0A9

Contacts

KMH Cardiology Centres (Mississauga)

Recruiting

Mississauga, Ontario, Canada, L5K 2L3

Contacts

Oakville Trafalgar Memorial Hospital

Recruiting

Oakville, Ontario, Canada, L6M 0L8

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

KMH Cardiology Centers (Hamilton)

Recruiting

Stoney Creek, Ontario, Canada, L8J 3W2

Contacts

Diabetes Heart Research Centre

Recruiting

Toronto, Ontario, Canada, M6G 1M2

Contacts

ViaCar Recherches Cliniques Inc. (Greenfield Park)

Recruiting

Greenfield Park, Quebec, Canada, J4V 2G8

Contacts

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Diex Recherche (Trois-Rivieres)

Recruiting

Trois-Rivières, Quebec, Canada, G9A 4P3

Contacts

Royal Alexandra Hospital (Edmonton)

Recruiting

Edmonton, Canada, T5H 3V9

Contacts

Health Sciences North

Recruiting

Greater Sudbury, Canada, P3E 5J1

Contacts

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Canada, H2X 0C1

Contacts

Montreal General Hospital - McGill University Health Centre

Recruiting

Montreal, Canada, H3G 1A4

Contacts

CardioVasc HR Inc.

Recruiting

Saint-Jean-sur-Richelieu, Canada, J3A 1J2

Contacts

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-21.