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NCT06424288

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

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

6000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2028-05-22

Brief Summary

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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.

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

TRIPLE

Participants Caregivers Investigators

Study Groups

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vicadrostat/empagliflozin

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 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

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

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

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1302-4422

Identifier Type: REGISTRY

Identifier Source: secondary_id

1378-0020

Identifier Type: -

Identifier Source: org_study_id

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

vicadrostat/empagliflozin

vicadrostat

empagliflozin

placebo/empagliflozin

empagliflozin

placebo

Interventions

vicadrostat

empagliflozin

placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Boehringer Ingelheim

Responsible Party

Locations

Diagnostic and Medical Clinic

Mobile Heart Specialists, PC

Velocity Clinical Research-Chula Vista

University of California Irvine

North America Research Institute

Orange County Research Center

Amicis Research Center (ARC)

Bridgeport Hospital

Excel Medical Clinical Trials

Bay Area Cardiology

Clearwater Cardiovascular and Interventional Consultants

Cardiology Associates Research Co.

Malcom Randall VA Medical Center

Velocity Clinical Research-Hallandale Beach-67888

University of Florida Health Jacksonville

East Coast Institute for Research, LLC-Jacksonville-55146

First Coast Cardiovascular Institute

Clearwater Cardiovascular Consultants-Largo-69917

University of Miami

Sacred Heart Medical Specialty Group

Advanced Research for Health Improvement, LLC

Southwest Florida Research, LLC

Ocala Cardiovascular Research

Ocala Research Institute, Inc

Charlotte Cardiovascular Institute, PA

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

University of South Florida

Cardiology Partners Clinical Research Institute

Cozy Research LLC

Clinical Site Partners, LLC

Atlanta Clinical Research Centers

Columbus Regional Research Institute

NSC Research Inc

Kootenai Medical Center

Northwest Heart Clinical Research, LLC

Illinois Masonic Hospital

Chicago Medical Research

Clinical Investigation Specialists, Inc.-Libertyville-69941

AMR Park Ridge

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

West Houston Area Clinical Trial Consultants, LLC

Norton Heart Specialists

Grace Research, LLC-Bossier City-51040

Heart Clinic of Hammond

Grace Research, LLC-Shreveport-64616

Louisiana Heart Center - Slidell

Ascension Saint Agnes Heart Care

AMR Dearborn

Sparrow Clinical Research Institute

Trinity Health Michigan D/B/A Michigan Heart