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A Study of Vicadrostat and Empagliflozin for Heart Failure

This study is for adults with chronic heart failure where the left side of the heart has a weak pumping function (reduced left ventricular ejection fraction, LVEF, less than 40%). You must have been diagnosed with chronic heart failure at least three months before joining. The study aims to see if a medicine called vicadrostat, when taken with empagliflozin, helps people with this condition. Participants will be randomly placed into one of two groups: one group receives vicadrostat and empagliflozin, and the other receives a placebo (an inactive substance that looks like vicadrostat) and empagliflozin. The main goal is to see if these medicines can reduce the risk of cardiovascular death, hospitalization for heart failure, or urgent heart failure visits over a period of up to 43 months. The study is currently recruiting 4200 participants.

Study design
This is an interventional study where participants are randomly assigned to one of two groups. One group receives vicadrostat and empagliflozin, and the other receives a placebo and empagliflozin.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 43 months to track events like cardiovascular death or hospitalizations for heart failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06935370

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~4,200 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:vicadrostatempagliflozinPlacebo

At a glance

Recruiting sites
559 of 588 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first event of Cardiovascular (CV) death, or Hospitalisation for heart failure (HHF), or Urgent heart failure (HF) visit
Measured over up to 43 months

Conditions

Heart Failure

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NCT06935370

Where you'd take part

This study runs at 588 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • 4. Military Clinical Hospital with Polyclinic SP ZOZ

    Wroclaw, Polandstudy coordinator listed

    Recruiting

  • Accurate Clinical Research, Inc.

    Richmond, Texasstudy coordinator listed

    Recruiting

  • Administradora Country S.A.S.

    Bogotá, Colombiastudy coordinator listed

    Recruiting

  • Advanced Heart Care, LLC

    Bridgewater, New Jerseystudy coordinator listed

    Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Chinastudy coordinator listed

    Recruiting

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Chinastudy coordinator listed

    Recruiting

  • Alexandrovska University Hospital

    Sofia, Bulgariastudy coordinator listed

    Recruiting

  • Alian s.r.o.

    Bardejov, Slovakiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Eligibility criteria

Exclusion

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

What this trial measures

  • Time to first event of Cardiovascular (CV) death, or Hospitalisation for heart failure (HHF), or Urgent heart failure (HF) visitup to 43 months