A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
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%
- Heart Failure
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Boehringer Ingelheim
- Enrolment target
- 6,712
- Started
- 17 June 2024
- Main results due (estimated)
- 22 May 2028
- Study ends (estimated)
- 22 May 2028
- Allocation
- Randomized
- Design
- Parallel
- Purpose
- Treatment
- Masking
- Triple (participant, care provider, investigator)
- Sites
- 664 · 14 in India
- First posted
- 22 May 2024
- Registry updated
- 1 October 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied. Healthy volunteers are not accepted.
Age groups: adult, older adult.
These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.
Read the full eligibility criteria
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.What this study is about
In the sponsor’s own words, from the registry.
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.
What participants receive
- Experimental
vicadrostat/empagliflozin
Drug: vicadrostat · Drug: empagliflozin
- Placebo comparator
placebo/empagliflozin
Drug: empagliflozin · Drug: placebo
Interventions
vicadrostatDrug
empagliflozinDrug
placeboDrug
placebo matching vicadrostat
What the study measures
Primary outcomes
Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
Time frame: up to 42 months
Secondary outcomes
Key secondary endpoint: Time to first event of CV death or HHF
Time frame: up to 42 months
Key secondary endpoint: Occurrence of HHFs (first and recurrent)
Time frame: up to 42 months
Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32
The Kansas City Cardiomyopathy Questionnaire is a patient-reported outcome instrument for use in clinical investigations in heart failure. The Total Symptom Score measures the following aspects of symptom experience in two domain scores: The "Symptom Frequency Domain" assesses frequency of the following experiences: * Lower extremity swelling in the morning * Fatigue limiting patients' ability to do what they want * Dyspnea limiting patients' ability to do what they want * Dyspnea forcing patients to sleep upright/elevated The "Symptom Burden Domain" assesses bothersomeness of the following symptoms: * Fatigue * Dyspnea * Lower extremity swelling All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: at baseline, at week 32
Key secondary endpoint: Time to CV death
Time frame: up to 42 months
Key secondary endpoint: Time to all-cause mortality
Time frame: up to 42 months
Time to first HHF
Time frame: up to 42 months
Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of ≥50% eGFR from baseline** or onset of sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 (composite renal endpoint)
\* chronic dialysis is defined as dialysis continuing for at least 30 days \*\* using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation ((CKD-EPI)cr)
Time frame: up to 42 months
Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32
The KCCQ Clinical Summary Score is a composite of the Total Symptom Score and Physical Limitations Score. The "Physical Limitations Score" measures the following physical limitations: * Dressing * Showering/bathing * Walking one block on level ground * Doing yardwork, housework or carrying groceries * Climbing a flight of stairs without stopping * Hurrying or jogging as if to catch a bus All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: at baseline, at week 32
Absolute change from baseline in KCCQ-TSS at Week 52
Time frame: at baseline, at week 52
Absolute change from baseline in KCCQ-OSS at Week 32
The Kansas City Cardiomyopathy Questionnaire - overall summary score (KCCQ-OSS) is a combination of the symptom \[domain\], physical limitations, social limitations, and quality of life domains. All KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame: at baseline, at week 32
Absolute change from baseline in KCCQ-OSS at Week 52
Time frame: at baseline, at week 52
Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥130 mmHg
Time frame: at baseline, at week 32
Absolute chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥80 mmHg
Time frame: at baseline, at week 32
Who is running it
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry
- Responsible party
- The sponsor
- Organisation
- Boehringer Ingelheim
- Data monitoring committee
- Yes
- US FDA-regulated drug
- Yes
- US FDA-regulated device
- No
- Sponsor's study ID
- 1378-0020
- Other IDs
- 2023-509706-30-00, U1111-1302-4422, 2023
Study sites(664)
Kamalnayan Bajaj Hospital
Aurangabad, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Narayana Institute of Cardiac Sciences
Bangalore, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Bangalore Medical college
Bengaluru, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
S.P. Medical College & Associated Group of Hospitals
Bikaner, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Tamil Nadu Government Multi Super Speciality Hospital TNGMSSH
Chennai, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Apollo Main Hospital
Chennai, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Lisie Hospital
Kochi, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
IPGMER and SSKM Hospital
Kolkata, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Chopda Medicare and Research Centre Pvt Ltd
Nashik, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Max Super Speciality Hospital
New Delhi, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Unicare Heart Institute
Surat, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
King George Hospital
Visakhapatnam, India
Recruiting
- Boehringer Ingelheim0008000501442india@bitrialsupport.com
Medanta-The Medicity
Gurgaon, India
Not yet recruiting
GNRC Hospital
Guwahati, India
Not yet recruiting
Diagnostic and Medical Clinic
Mobile, Alabama, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Mobile Heart Specialists, PC
Mobile, Alabama, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Velocity Clinical Research-Chula Vista
Chula Vista, California, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
University of California Irvine
Orange, California, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
North America Research Institute
San Dimas, California, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Amicis Research Center - Valencia
Santa Clarita, California, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Orange County Research Center
Tustin, California, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Bridgeport Hospital
Bridgeport, Connecticut, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Flourish Research
Boca Raton, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Bay Area Cardiology
Brandon, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Clearwater Cardiovascular and Interventional Consultants
Clearwater, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Cardiology Associates Research Co.
Daytona Beach, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Malcom Randall VA Medical Center
Gainesville, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Velocity Clinical Research-Hallandale Beach-67888
Hallandale, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
East Coast Institute for Research, LLC - Jacksonville
Jacksonville, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Clearwater Cardiovascular Consultants-Largo-69917
Largo, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
University of Miami
Miami, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Sacred Heart Medical Specialty Group
Miramar Beach, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Southwest Florida Research, LLC
Naples, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Ocala Cardiovascular Research
Ocala, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Ocala Research Institute, Inc
Ocala, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Charlotte Cardiovascular Institute, PA
Port Charlotte, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
East Coast Institute for Research, LLC-Saint Augustine-63032
Saint Augustine, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
University of South Florida
Tampa, Florida, United States
Recruiting
- Boehringer Ingelheim833-602-2368unitedstates@bitrialsupport.com
Showing 40 of 664 sites, filter to narrow it down. 623 of 664 on this study are recruiting right now, and 14 are in India. A site can stop enrolling while the study as a whole is still open.
References and data sharing
- Participant data shared
- Yes
- What is shared
- Study protocol, Sap, Csr
- When
- One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
- Access
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Source: ClinicalTrials.gov record NCT06424288, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Interested in this study?
Tell us how to reach you and we will connect you with the study team. Or refer someone you care for, with their permission.
