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Clinical Trials in the UK / NCT06424288
Recruiting Phase 3

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

NCT06424288 · tracked via the Priya Life Science UK tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2024-06-17
Last updated
2026-08-21

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

vicadrostatempagliflozinplacebo

vicadrostat: vicadrostat

empagliflozin: empagliflozin

placebo: placebo matching vicadrostat

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (652)

FacilityCityRegionStatus
Diagnostic and Medical Clinic Mobile Alabama Recruiting
Mobile Heart Specialists, PC Mobile Alabama Recruiting
Velocity Clinical Research-Chula Vista Chula Vista California Recruiting
University of California Irvine Orange California Recruiting
North America Research Institute San Dimas California Recruiting
Amicis Research Center - Valencia Santa Clarita California Recruiting
Orange County Research Center Tustin California Recruiting
Bridgeport Hospital Bridgeport Connecticut Recruiting
Excel Medical Clinical Trials Boca Raton Florida Recruiting
Bay Area Cardiology Brandon Florida Recruiting
Clearwater Cardiovascular and Interventional Consultants Clearwater Florida Recruiting
Cardiology Associates Research Co. Daytona Beach Florida Recruiting
Malcom Randall VA Medical Center Gainesville Florida Recruiting
Velocity Clinical Research-Hallandale Beach-67888 Hallandale Florida Recruiting
University of Florida Health Jacksonville Jacksonville Florida Recruiting
East Coast Institute for Research, LLC - Jacksonville Jacksonville Florida Recruiting
First Coast Cardiovascular Institute Jacksonville Florida Recruiting
Clearwater Cardiovascular Consultants-Largo-69917 Largo Florida Recruiting
University of Miami Miami Florida Recruiting
Sacred Heart Medical Specialty Group Miramar Beach Florida Recruiting
Advanced Research for Health Improvement, LLC Naples Florida Not Yet Recruiting
Southwest Florida Research, LLC Naples Florida Recruiting
Ocala Cardiovascular Research Ocala Florida Recruiting
Ocala Research Institute, Inc Ocala Florida Recruiting
Charlotte Cardiovascular Institute, PA Port Charlotte Florida Recruiting
East Coast Institute for Research, LLC-Saint Augustine-63032 Saint Augustine Florida Recruiting
University of South Florida Tampa Florida Recruiting
Cardiology Partners Clinical Research Institute Wellington Florida Recruiting
Cozy Research LLC Wesley Chapel Florida Recruiting
Clinical Site Partners, LLC Winter Park Florida Recruiting
Atlanta Clinical Research Centers Atlanta Georgia Recruiting
Columbus Regional Research Institute Columbus Georgia Recruiting
NSC Research Inc Johns Creek Georgia Recruiting
Kootenai Medical Center Coeur d'Alene Idaho Recruiting
Northwest Heart Clinical Research, LLC Arlington Heights Illinois Recruiting
Illinois Masonic Hospital Chicago Illinois Recruiting
Chicago Medical Research Hazel Crest Illinois Recruiting
Clinical Investigation Specialists, Inc.-Libertyville-69941 Libertyville Illinois Recruiting
AMR Park Ridge Park Ridge Illinois Recruiting
Midwest Cardiovascular Research and Education Foundation Elkhart Indiana Recruiting

+ 612 more sites — see the full list on the official registry below.

On this site

📄 Jardiance (empagliflozin) drug profile →

More Boehringer Ingelheim trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06424288 on ClinicalTrials.gov ↗ ← All trials in the UK