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

NCT IDNCT06935370ClinicalTrials.gov data as of Apr 2026

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Phase

Phase 3

Target enrollment

4,200

Study length

about 3.8 years

Ages

18+

Locations

107 sites in AL, CA, CT +23

What this study is about

This trial is testing whether vicadrostat, combined with empagliflozin, helps people with heart failure who have a weak left side of their heart. Participants will take either vicadrostat/empagliflozin or placebo/empagliflozin tablets daily for up to 3.5 years while continuing their regular heart failure treatment. It team will monitor participants' health and symptoms, comparing outcomes between the two groups.

Simplified from trial records by PatientMatch.

What you may be asked to do

1.Take Placebo
2.Take empagliflozin
3.Take vicadrostat

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel

In-person visits

Requires travel to a study site

Physical Intervention

Oral

How treatment is administered

Treatment Assignment

Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

empagliflozin (SGLT2 inhibitor; increases glucose excretion in urine)

Drug routes

oral (Oral Tablet)

Endpoints

Secondary: Absolute change from baseline in KCCQ-OSS at Week 52, Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire- Clinical Summary Score (KCCQ-CSS) at Week 32, Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire- Overall Summary Score (KCCQ-OSS) at Week 32, Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 52, Absolute change from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥ 80 mmHg, Absolute change from baseline in systolic blood pressure (SBP) [mmHg] at Week 32 in participants with baseline SBP ≥ 130 mmHg, Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 32, Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or onset of sustained reduction of ≥ 50% estimated glomerular filtration rate (eGFR) or onset of sustained eGFR (CKD-EPI)cr < 10 mL/min/1.73 m²

Body systems

Cardiology / Heart

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