RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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%

Quick Facts

Study Start:2024-06-17

Study Completion:2028-05-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06424288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Boehringer Ingelheim

CONTACT

1-800-243-0127

lintriage.rdg@boehringer-ingelheim.com

Study Locations (Sites)

Diagnostic and Medical Clinic

Mobile, Alabama, 36604

United States

Mobile Heart Specialists, PC

Mobile, Alabama, 36608

United States

Velocity Clinical Research-Chula Vista

Chula Vista, California, 91911

United States

University of California Irvine

Orange, California, 92868

United States

North America Research Institute

San Dimas, California, 91773

United States

Orange County Research Center

Tustin, California, 92780

United States

Amicis Research Center (ARC)

Valencia, California, 91355

United States

Bridgeport Hospital

Bridgeport, Connecticut, 06610

United States

Excel Medical Clinical Trials

Boca Raton, Florida, 33434

United States

Bay Area Cardiology

Brandon, Florida, 33511

United States

Clearwater Cardiovascular and Interventional Consultants

Clearwater, Florida, 33756

United States

Cardiology Associates Research Co.

Daytona Beach, Florida, 32117

United States

Malcom Randall VA Medical Center

Gainesville, Florida, 32608

United States

Velocity Clinical Research-Hallandale Beach-67888

Hallandale, Florida, 33009

United States

University of Florida Health Jacksonville

Jacksonville, Florida, 32209

United States

East Coast Institute for Research, LLC-Jacksonville-55146

Jacksonville, Florida, 32216

United States

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256

United States

Clearwater Cardiovascular Consultants-Largo-69917

Largo, Florida, 33777

United States

University of Miami

Miami, Florida, 33136

United States

Sacred Heart Medical Specialty Group

Miramar Beach, Florida, 32550

United States

Advanced Research for Health Improvement, LLC

Naples, Florida, 34102

United States

Southwest Florida Research, LLC

Naples, Florida, 34102

United States

Ocala Cardiovascular Research

Ocala, Florida, 34471

United States

Ocala Research Institute, Inc

Ocala, Florida, 34471

United States

Charlotte Cardiovascular Institute, PA

Port Charlotte, Florida, 33952

United States

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

Saint Augustine, Florida, 32086

United States

University of South Florida

Tampa, Florida, 33612

United States

Cardiology Partners Clinical Research Institute

Wellington, Florida, 33449

United States

Cozy Research LLC

Wesley Chapel, Florida, 33544

United States

Clinical Site Partners, LLC

Winter Park, Florida, 32789

United States

Atlanta Clinical Research Centers

Atlanta, Georgia, 30342

United States

Columbus Regional Research Institute

Columbus, Georgia, 31904

United States

NSC Research Inc

Johns Creek, Georgia, 30024

United States

Kootenai Medical Center

Coeur d'Alene, Idaho, 83814

United States

Northwest Heart Clinical Research, LLC

Arlington Heights, Illinois, 60005

United States

Illinois Masonic Hospital

Chicago, Illinois, 60657

United States

Chicago Medical Research

Hazel Crest, Illinois, 60429

United States

Clinical Investigation Specialists, Inc.-Libertyville-69941

Libertyville, Illinois, 60048

United States

AMR Park Ridge

Park Ridge, Illinois, 60068

United States

Midwest Cardiovascular Research and Education Foundation

Elkhart, Indiana, 46514

United States

St. Francis Medical Group-Indiana Heart Physicians, Inc

Indianapolis, Indiana, 46237

United States

Indiana Medical Research Institute

Merrillville, Indiana, 46410

United States

Cardiovascular Research of Northwest Indiana, LLC

Munster, Indiana, 46321

United States

Reid Hospital

Richmond, Indiana, 47374

United States

The Iowa Clinic, PC

West Des Moines, Iowa, 50266

United States

West Houston Area Clinical Trial Consultants, LLC

Wichita, Kansas, 67226

United States

Norton Heart Specialists

Louisville, Kentucky, 40205

United States

Grace Research, LLC-Bossier City-51040

Bossier City, Louisiana, 71111

United States

Heart Clinic of Hammond

Hammond, Louisiana, 70403

United States

Grace Research, LLC-Shreveport-64616

Shreveport, Louisiana, 71105

United States

Louisiana Heart Center - Slidell

Slidell, Louisiana, 70458

United States

Ascension Saint Agnes Heart Care

Baltimore, Maryland, 21229

United States

AMR Dearborn

Dearborn, Michigan, 48126

United States

Sparrow Clinical Research Institute

Lansing, Michigan, 48910-0826

United States

Trinity Health Michigan D/B/A Michigan Heart

Ypsilanti, Michigan, 48197

United States

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417

United States

Jackson Heart Clinic, P.A.

Jackson, Mississippi, 39216

United States

Kansas City VA Medical Center

Kansas City, Missouri, 64128

United States

North Kansas City Hospital

North Kansas City, Missouri, 64116

United States

St. Louis Heart and Vascular, P.C.

St Louis, Missouri, 63136

United States

Velocity Clinical Research-Lincoln-69943

Lincoln, Nebraska, 68506

United States

Advanced Heart Care, LLC

Bridgewater, New Jersey, 08807

United States

Garden State Heart Care, PC

Manalapan, New Jersey, 07726

United States

Cardio Metabolic Institute

Somerset, New Jersey, 08873

United States

NYU Langone Health

New York, New York, 10001

United States

Mount Sinai Hospital-New York-52529

New York, New York, 10029

United States

Cardiac Care and Vascular Medicine, PLLC

The Bronx, New York, 10469

United States

Medication Management, LLC

Greensboro, North Carolina, 27405

United States

WakeMed

Raleigh, North Carolina, 27610

United States

K and R Research LLC

Marion, Ohio, 43302

United States

Mercy Health St. Vincent Medical Center

Toledo, Ohio, 43608

United States

Bon Secours Medical Group Greenville Specialty Care, LLC

Greenville, South Carolina, 29607

United States

Monument Health

Rapid City, South Dakota, 57701

United States

Helios CR Inc

Jackson, Tennessee, 38305

United States

East Coast Institute For Research LLC

Jefferson City, Tennessee, 37760

United States

Pharmatex Research

Amarillo, Texas, 79109

United States

Amarillo Heart Clinical Research Institute, Incorporated

Amarillo, Texas, 79124

United States

Texas Health Research and Education Institute

Dallas, Texas, 75231

United States

Texas Health Research and Education Institute

Dallas, Texas, 75231

United States

Southwest Family Medicine Associates

Dallas, Texas, 75235

United States

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

United States

Helios CR Inc

Fort Worth, Texas, 76104

United States

Private Practice Leadership, LLC

Katy, Texas, 77493

United States

Texas Cardiology Research Center PLLC

Kingwood, Texas, 77339

United States

DCOL Center for Clinical Research

Longview, Texas, 75605

United States

North Texas Research Associates

McKinney, Texas, 75071

United States

Texas Institute Of Cardiology

McKinney, Texas, 75071

United States

University of Utah Hospital

Salt Lake City, Utah, 84132

United States

Carient Heart and Vascular

Manassas, Virginia, 20109

United States

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507

United States

Selma Medical Associates, Winchester

Winchester, Virginia, 22601

United States

Virginia Mason Medical Center

Seattle, Washington, 98101

United States

Drug Research and Analysis Corporation

Madison, Wisconsin, 53717

United States

ProHealth Care Research Institute and Cardiology Associates

Waukesha, Wisconsin, 53188

United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-17

Study Completion Date2028-05-22

Study Record Updates

Study Start Date2024-06-17

Study Completion Date2028-05-22

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure