Back to search results

A Study of Vicadrostat and Empagliflozin for Heart Failure

This study is for adults aged 18 or older with heart failure who have symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. We are testing if a combination of vicadrostat and empagliflozin helps people with heart failure. Participants will be randomly assigned to one of two groups: one receiving vicadrostat and empagliflozin, and the other receiving a placebo (an inactive substance) and empagliflozin. Both are taken as tablets once a day. The main goal is to see if this combination can reduce serious heart-related events like cardiovascular death or hospital stays for heart failure over a period of up to 42 months. This study plans to enroll 6000 people, but its current status is unclear.

Study design
This is an interventional study with 6000 planned participants. You would be randomly assigned to one of two groups: vicadrostat/empagliflozin or placebo/empagliflozin.
What's involved
You would take study tablets once a day. You can stay in the study as long as you benefit from the treatment and can tolerate it.
Compensation
Not stated in the trial record.
Follow-up
The study will track your health for up to 42 months to see if the treatment reduces heart-related events.

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

NCT06424288

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~6,000 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:vicadrostatempagliflozinplacebo

At a glance

Recruiting sites
621 of 652 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visit
Measured over up to 42 months

Conditions

Heart Failure

Explore related trials

Heart Failure

NCT06424288

Where you'd take part

This study runs at 652 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

  • Advanced Heart Care, LLC

    Bridgewater, New Jerseystudy coordinator listed

    Recruiting

  • Advanced Research for Health Improvement, LLC

    Naples, Floridastudy coordinator listed

    Not yet recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Chinastudy coordinator listed

    Recruiting

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Chinastudy coordinator listed

    Recruiting

  • Afyon Kocatepe University Medical Faculty

    Afyonkarahisar, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Aka-Med Centrum Sp. z o.o. S.K.

    Ruda Śląska, Polandstudy coordinator listed

    Recruiting

  • Alexandrovska University Hospital

    Sofia, Bulgariastudy 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

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • Time to first event of Cardiovascular (CV) death, hospitalisation for heart failure (HHF) or urgent heart failure (HF) visitup to 42 months