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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

RecruitingPhase 3

EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) < 40%

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Boehringer Ingelheim · Participants: 4,200 · Started: May 20, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06935370

Locations in the U.S.

CaliforniaValley Clinical Trials, Inc., Covina
North Coast Cardiology, Encinitas (Not yet recruiting)
Merced Vein and Vascular Center, Merced
Radin Cardiovascular Medical Group, Newport Beach
Paradigm Clinical Research - San Diego, San Diego
University of California San Diego, San Diego (Not yet recruiting)
Care Access Research, Thousand Oaks
FloridaBay Area Cardiology, Brandon
Cardiology Associates Research Co., Daytona Beach
Suncoast Research Associates, LLC, Doral
Malcom Randall VA Medical Center, Gainesville
Velocity Clinical Research-Hallandale Beach-67888, Hallandale
East Coast Institute For Research, LLC, Jacksonville
Jacksonville Center for Clinical Research, Jacksonville
University of Florida, Jacksonville
Infinite Clinical Research Inc, Miami
University of Miami - Miller School of Medicine, Miami
Inpatient Research Clinic, LLC, Miami Lakes
Innovation Medical Research Center, Palmetto Bay
Peace River Cardiovascular Center, Port Charlotte
St. Johns Center for Clinical Research, Saint Augustine
University of South Florida, Tampa
Cardiology Partners Clinical Research Institute, Wellington
Cozy Research LLC, Wesley Chapel
Clinical Site Partners, LLC, Winter Park
GeorgiaAtlanta Clinical Research Centers, Atlanta
NSC Research Inc, Johns Creek
IllinoisNorthwest Heart Clinical Research, LLC, Arlington Heights (Not yet recruiting)
Illinois Masonic Hospital, Chicago (Not yet recruiting)
Chicago Medical Research, Hazel Crest
Clinical Investigation Specialists, Inc., Libertyville
AMR Park Ridge, Park Ridge
Springfield Clinic, Springfield
IndianaMidwest Cardiovascular Research and Education Foundation, Elkhart
St. Francis Medical Group-Indiana Heart Physicians, Inc, Indianapolis
Cardiovascular Research of Northwest Indiana, LLC, Munster
Reid Hospital, Richmond
IowaThe Iowa Clinic, PC, West Des Moines
KansasUniversity of Kansas Medical Center, Kansas City (Not yet recruiting)
Kansas Nephrology Research Institute, LLC, Wichita
Robert J Dole Veterans Affairs Medical Center, Wichita
West Houston Area Clinical Trial Consultants, LLC, Wichita
LouisianaHeart Clinic of Hammond, Hammond
MarylandAscension Saint Agnes Heart Care, Baltimore
Metropolitan Cardiovascular Consultants, Beltsville
Capitol Cardiology Associates, Lanham
MichiganCardiology and Vascular Associates - CAVA, Bloomfield Hills
Henry Ford Providence Hospital, Southfield
Michigan Heart, PC, Ypsilanti
MinnesotaMinneapolis VA Health Care System, Minneapolis
Mayo Clinic, Rochester, Rochester
Regions Hospital, Saint Paul
MissouriKansas City VA Medical Center, Kansas City
St. Louis Heart and Vascular, P.C., St Louis
NebraskaBe Well Clinical Studies, Omaha
New JerseyAdvanced Heart Care, LLC, Bridgewater
New YorkIcahn School of Medicine at Mount Sinai, New York
Mount Sinai Hospital-New York-52529, New York
North CarolinaIMA Clinical Research Lenoir, Lenoir
Pinehurst Medical Clinic, Inc. - East, Pinehurst
WakeMed, Raleigh
Piedmont Healthcare, Inc., Statesville
Wilmington Health, Wilmington
OhioVA Northeast Ohio Healthcare System, Cleveland (Not yet recruiting)
K and R Research LLC, Marion
PennsylvaniaCardiology Consultants of Philadelphia, Yardley
TexasAmarillo Heart Clinical Research Institute, Incorporated, Amarillo
Pharmatex Research, Amarillo
NextStage Clinical Research, Beaumont
Clinical Research Solution, LLC, Cypress
Southwest Family Medicine Associates, Dallas
Texas Health Research and Education Institute, Dallas
Helios CR Inc - Fort Worth, Fort Worth
The Methodist Hospital Research Institute, Houston
DM Clinical Research - Irving, Irving
DCOL Center for Clinical Research, Longview
North Texas Research Associates, McKinney
Revival Research Institute, LLC - McKinney, McKinney
Texas Institute Of Cardiology, McKinney
Accurate Clinical Research, Inc., Richmond
Baylor Scott and White Health, Temple
Northwest Heart Center, Tomball
NextStage Clinical Research, Waco
VirginiaCarient Heart and Vascular, Manassas
Carilion Clinic, Roanoke

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.