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RECRUITING

NCT06424288

PHASE3

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

Official title: EASi-HF Preserved - 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 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

6712

Start Date

2024-06-17

Completion Date

2028-05-22

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 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.

Locations (671)

Diagnostic and Medical Clinic

Mobile, Alabama, United States

Mobile Heart Specialists, PC

Mobile, Alabama, United States

Velocity Clinical Research-Chula Vista

Chula Vista, California, United States

University of California Irvine

Orange, California, United States

North America Research Institute

San Dimas, California, United States

Amicis Research Center - Valencia

Santa Clarita, California, United States

Orange County Research Center

Tustin, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Flourish Research

Boca Raton, Florida, United States

Bay Area Cardiology

Brandon, Florida, United States

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, United States

Cardiology Associates Research Co.

Daytona Beach, 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 Health Jacksonville

Jacksonville, Florida, United States

East Coast Institute for Research, LLC - Jacksonville

Jacksonville, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Clearwater Cardiovascular Consultants-Largo-69917

Largo, Florida, United States

University of Miami

Miami, Florida, United States

Sacred Heart Medical Specialty Group

Miramar Beach, Florida, United States

Advanced Research for Health Improvement, LLC

Naples, Florida, United States

Southwest Florida Research, LLC

Naples, Florida, United States

Ocala Cardiovascular Research

Ocala, Florida, United States

Ocala Research Institute, Inc

Ocala, Florida, United States

Charlotte Cardiovascular Institute, PA

Port Charlotte, Florida, United States

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

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

Columbus Regional Research Institute

Columbus, Georgia, United States

NSC Research Inc

Johns Creek, Georgia, United States

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Northwest Heart Clinical Research, LLC

Arlington Heights, Illinois, United States

Illinois Masonic Hospital

Chicago, Illinois, United States

Chicago Medical Research

Hazel Crest, Illinois, United States

Clinical Investigation Specialists, Inc.-Libertyville-69941

Libertyville, Illinois, United States

AMR Park Ridge

Park Ridge, 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

West Houston Area Clinical Trial Consultants, LLC - Wichita

Wichita, Kansas, United States

Norton Heart Specialists

Louisville, Kentucky, United States

Grace Research, LLC-Bossier City-51040

Bossier City, Louisiana, United States

Heart Clinic of Hammond

Hammond, Louisiana, United States

Grace Research, LLC-Shreveport-64616

Shreveport, Louisiana, United States

Louisiana Heart Center - Slidell

Slidell, Louisiana, United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland, United States

AMR Dearborn

Dearborn, Michigan, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Henry Ford Providence Hospital

Southfield, Michigan, United States

Trinity Health Michigan D/B/A Michigan Heart

Ypsilanti, Michigan, United States

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Jackson Heart Clinic, P.A.

Jackson, Mississippi, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

North Kansas City Hospital

North Kansas City, Missouri, United States

St. Louis Heart and Vascular, P.C.

St Louis, Missouri, United States

Velocity Clinical Research-Lincoln-69943

Lincoln, Nebraska, United States

Advanced Heart Care, LLC

Bridgewater, New Jersey, United States

Garden State Heart Care, PC

Manalapan, New Jersey, United States

Cardio Metabolic Institute

Somerset, New Jersey, United States

NYU Langone Health

New York, New York, United States

Mount Sinai Hospital-New York-52529

New York, New York, United States

Cardiac Care and Vascular Medicine, PLLC

The Bronx, New York, United States

Medication Management, LLC

Greensboro, North Carolina, United States

WakeMed

Raleigh, North Carolina, United States

K and R Research LLC

Marion, Ohio, United States

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Bon Secours Medical Group Greenville Specialty Care, LLC

Greenville, South Carolina, United States

Monument Health

Rapid City, South Dakota, United States

Helios CR Inc

Jackson, Tennessee, United States

East Coast Institute For Research LLC

Jefferson City, Tennessee, United States

Pharmatex Research

Amarillo, Texas, United States

Amarillo Heart Clinical Research Institute, Incorporated

Amarillo, Texas, United States

Texas Health Research and Education Institute

Dallas, Texas, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Helios CR Inc

Fort Worth, Texas, United States

West Houston Area Clinical Trial Consultants, LLC - Katy

Katy, Texas, United States

Texas Cardiology Research Center PLLC

Kingwood, Texas, United States

DCOL Center for Clinical Research

Longview, Texas, United States

North Texas Research Associates

McKinney, Texas, United States

Texas Institute Of Cardiology

McKinney, Texas, United States

University of Utah Health

Salt Lake City, Utah, United States

Carient Heart and Vascular

Manassas, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Selma Medical Associates, Winchester

Winchester, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Drug Research and Analysis Corporation

Madison, Wisconsin, United States

ProHealth Care Research Institute and Cardiology Associates

Waukesha, Wisconsin, United States

Inst de Inv Clinicas-Bahia Blanca

Bahía Blanca, Argentina

CPSIC SRL - Cardiologia Palermo

Buenos Aires, Argentina

Swiss Medical Center Barrio Parque

Buenos Aire, Argentina

Organizacion Medica de Investigacion (OMI)

Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Metabolicas (CINME)-Ciudad Autonoma Buenos Aires-41221

Ciudad Autonoma Buenos Aires, Argentina

Mautalen- Salud e Investigacion

Ciudad Autonoma Buenos Aires, Argentina

And 571 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (671)