🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT06935370
Recruiting Phase 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

NCT06935370 · tracked via the Priya Life Science India tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2025-05-20
Last updated
2026-09-03

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 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.

Eligibility

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

Primary outcome measure(s)

Trial sites (588)

FacilityCityRegionStatus
Cure Clinical Research Beverly Hills California Suspended
Valley Clinical Trials, Inc. Covina California Recruiting
North Coast Cardiology Encinitas California Not Yet Recruiting
Merced Vein and Vascular Center Merced California Recruiting
Radin Cardiovascular Medical Group Newport Beach California Recruiting
Amicis Research Center - Nordhoff Northridge California Terminated
University of California San Diego San Diego California Not Yet Recruiting
Paradigm Clinical Research - San Diego San Diego California Recruiting
Amicis Research Corporate Santa Clarita California Terminated
Care Access Research Thousand Oaks California Recruiting
Bay Area Cardiology Brandon Florida Recruiting
Cardiology Associates Research Co. Daytona Beach Florida Recruiting
Suncoast Research Associates, LLC Doral Florida Recruiting
Malcom Randall VA Medical Center Gainesville Florida Recruiting
Velocity Clinical Research-Hallandale Beach-67888 Hallandale Florida Recruiting
University of Florida Jacksonville Florida Recruiting
East Coast Institute For Research, LLC Jacksonville Florida Recruiting
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
University of Miami - Miller School of Medicine Miami Florida Recruiting
Infinite Clinical Research Inc Miami Florida Recruiting
Inpatient Research Clinic, LLC Miami Lakes Florida Recruiting
Innovation Medical Research Center Palmetto Bay Florida Recruiting
Peace River Cardiovascular Center Port Charlotte Florida Recruiting
St. Johns Center for Clinical Research 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
NSC Research Inc Johns Creek Georgia Recruiting
Northwest Heart Clinical Research, LLC Arlington Heights Illinois Not Yet Recruiting
Illinois Masonic Hospital Chicago Illinois Not Yet Recruiting
Chicago Medical Research Hazel Crest Illinois Recruiting
Clinical Investigation Specialists, Inc. Libertyville Illinois Recruiting
AMR Park Ridge Park Ridge Illinois Recruiting
Springfield Clinic Springfield Illinois Recruiting
Midwest Cardiovascular Research and Education Foundation Elkhart Indiana Recruiting
St. Francis Medical Group-Indiana Heart Physicians, Inc Indianapolis Indiana Recruiting
Cardiovascular Research of Northwest Indiana, LLC Munster Indiana Recruiting
Reid Hospital Richmond Indiana Recruiting

+ 548 more sites — see the full list on the official registry below.

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 NCT06935370 on ClinicalTrials.gov ↗ ← All trials in India