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Vicadrostat plus empagliflozin for people with heart failure and reduced left-sided pumping function

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%

Phase 3 Interventional Boehringer Ingelheim · NCT06935370

This trial will test whether adding vicadrostat to empagliflozin helps adults with chronic heart failure who have a reduced left ventricular ejection fraction.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment4200 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionschemotherapy
Locations639 sites (Mobile, Alabama and 638 other locations)
Trial IDNCT06935370 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, placebo-controlled trial enrolls adults with chronic heart failure (diagnosed ≥3 months) and LVEF <40% (NYHA class II–IV). Participants are randomly assigned to receive either vicadrostat with empagliflozin or placebo with empagliflozin, taken once daily, with treatment lasting from about 6 months up to about 3.5 years. Matching placebo tablets are used and participants may continue their usual heart failure therapies during the trial. The study compares clinical outcomes between the combination and empagliflozin plus placebo groups to see if vicadrostat adds benefit.

Who should consider this trial

Good fit: Adults (≥18 years) with chronic heart failure diagnosed at least 3 months earlier, NYHA class II–IV, and LVEF <40% who can take empagliflozin and meet safety criteria are the intended participants.

Not a fit: People with preserved ejection fraction (LVEF ≥40%), very recent-onset heart failure (<3 months), contraindications to empagliflozin, or certain severe comorbidities are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could further reduce heart failure symptoms, lower hospitalizations, and improve longer-term outcomes for people with reduced LVEF.

How similar studies have performed: SGLT2 inhibitors such as empagliflozin have proven benefit in HFrEF, while vicadrostat is an investigational agent being tested in combination and its added effect remains unproven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Mobile, Alabama and 638 other locations

+589 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 2026-06-13 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.