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Testing Vicadrostat with Empagliflozin for 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%

Phase 3 Interventional Boehringer Ingelheim · NCT06424288

This study is testing if a new drug called vicadrostat, when taken with empagliflozin, can help adults with heart failure feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment6000 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionschemotherapy
Locations653 sites (Mobile, Alabama and 652 other locations)
Trial IDNCT06424288 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of vicadrostat in combination with empagliflozin for adults suffering from heart failure. Participants will be randomly assigned to receive either the combination of vicadrostat and empagliflozin or a placebo with empagliflozin. The study will monitor participants' health and any side effects throughout the treatment period. Regular doctor visits and follow-ups will ensure comprehensive care and data collection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic heart failure and a left ventricular ejection fraction of 40% or more.

Not a fit: Patients with heart failure symptoms but an LVEF below 40% or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve heart failure management and enhance patients' quality of life.

How similar studies have performed: Previous studies have shown promising results with similar combinations of heart failure treatments, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Mobile, Alabama and 652 other locations

+603 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.