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RECRUITING

NCT06935370

PHASE3

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: 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%

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4200

Start Date

2025-05-20

Completion Date

2029-02-22

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Heart Failure

Interventions

DRUG

vicadrostat

DRUG

empagliflozin

DRUG

Placebo

Placebo matching vicadrostat

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.

Locations (594)

Cure Clinical Research

Beverly Hills, California, United States

Valley Clinical Trials, Inc.

Covina, California, United States

North Coast Cardiology

Encinitas, California, United States

Merced Vein and Vascular Center

Merced, California, United States

Radin Cardiovascular Medical Group

Newport Beach, California, United States

Amicis Research Center - Nordhoff

Northridge, California, United States

University of California San Diego

San Diego, California, United States

Paradigm Clinical Research - San Diego

San Diego, California, United States

Amicis Research Corporate

Santa Clarita, California, United States

Care Access Research

Thousand Oaks, California, United States

Bay Area Cardiology

Brandon, Florida, United States

Cardiology Associates Research Co.

Daytona Beach, Florida, United States

Suncoast Research Associates, LLC

Doral, Florida, United States

Malcom Randall VA Medical Center

Gainesville, Florida, United States

Velocity Clinical Research-Hallandale Beach-67888

Hallandale, Florida, United States

University of Florida

Jacksonville, Florida, United States

East Coast Institute For Research, LLC

Jacksonville, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

University of Miami - Miller School of Medicine

Miami, Florida, United States

Infinite Clinical Research Inc

Miami, Florida, United States

Inpatient Research Clinic, LLC

Miami Lakes, Florida, United States

Innovation Medical Research Center

Palmetto Bay, Florida, United States

Peace River Cardiovascular Center

Port Charlotte, Florida, United States

St. Johns Center for Clinical Research

Saint Augustine, Florida, United States

University of South Florida

Tampa, Florida, United States

Cardiology Partners Clinical Research Institute

Wellington, Florida, United States

Cozy Research LLC

Wesley Chapel, Florida, United States

Flourish Research

Winter Park, Florida, United States

Atlanta Clinical Research Centers

Atlanta, Georgia, United States

NSC Research Inc

Johns Creek, Georgia, United States

Northwest Heart Clinical Research, LLC

Arlington Heights, Illinois, United States

Chicago Medical Research

Hazel Crest, Illinois, United States

Clinical Investigation Specialists, Inc.

Libertyville, Illinois, United States

AMR Park Ridge

Park Ridge, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Midwest Cardiovascular Research and Education Foundation

Elkhart, Indiana, United States

St. Francis Medical Group-Indiana Heart Physicians, Inc

Indianapolis, Indiana, United States

Indiana Medical Research Institute

Merrillville, Indiana, United States

Cardiovascular Research of Northwest Indiana, LLC

Munster, Indiana, United States

Reid Hospital

Richmond, Indiana, United States

The Iowa Clinic, PC

West Des Moines, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kansas Nephrology Research Institute, LLC

Wichita, Kansas, United States

Robert J Dole Veterans Affairs Medical Center

Wichita, Kansas, United States

West Houston Area Clinical Trial Consultants, LLC - Wichita

Wichita, Kansas, United States

Heart Clinic of Hammond

Hammond, Louisiana, United States

Grace Research, LLC-Shreveport-64616

Shreveport, Louisiana, United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

Metropolitan Cardiovascular Consultants

Beltsville, Maryland, United States

Capitol Cardiology Associates

Lanham, Maryland, United States

Cardiology and Vascular Associates - CAVA

Bloomfield Hills, Michigan, United States

Michigan Healthcare Professionals Pulse Cardiology

Farmington Hills, Michigan, United States

Henry Ford Providence Hospital

Southfield, Michigan, United States

Michigan Heart, PC

Ypsilanti, Michigan, United States

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

St. Louis Heart and Vascular, P.C.

St Louis, Missouri, United States

Be Well Clinical Studies

Omaha, Nebraska, United States

Advanced Heart Care, LLC

Bridgewater, New Jersey, United States

Mount Sinai Hospital-New York-52529

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

IMA Clinical Research Lenoir

Lenoir, North Carolina, United States

Pinehurst Medical Clinic, Inc. - East

Pinehurst, North Carolina, United States

Piedmont Healthcare, Inc.

Statesville, North Carolina, United States

Wilmington Health

Wilmington, North Carolina, United States

VA Northeast Ohio Healthcare System

Cleveland, Ohio, United States

K and R Research LLC

Marion, Ohio, United States

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, United States

Bon Secours Medical Group Greenville Specialty Care, LLC

Greenville, South Carolina, United States

Pharmatex Research

Amarillo, Texas, United States

Amarillo Heart Clinical Research Institute, Incorporated

Amarillo, Texas, United States

NextStage Clinical Research

Beaumont, Texas, United States

Clinical Research Solution, LLC

Cypress, Texas, United States

Texas Health Research and Education Institute

Dallas, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

Helios CR Inc - Fort Worth

Fort Worth, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

DM Clinical Research

Irving, Texas, United States

DCOL Center for Clinical Research

Longview, Texas, United States

North Texas Research Associates

McKinney, Texas, United States

Revival Research Institute, LLC - McKinney

McKinney, Texas, United States

Texas Institute Of Cardiology

McKinney, Texas, United States

Accurate Clinical Research, Inc.

Richmond, Texas, United States

Northwest Heart Center

Tomball, Texas, United States

NextStage Clinical Research

Waco, Texas, United States

Carient Heart and Vascular

Manassas, Virginia, United States

Carilion Clinic

Roanoke, Virginia, United States

Inst de Inv Clinicas-Bahia Blanca

Bahía Blanca, Argentina

Hospital Regional de Bahia Blanca

Bahía Blanca, Argentina

Centro de Investigaciones Metabolicas (CINME)

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires