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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

Boehringer Ingelheim
NCT IDNCT06935370ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

4,200

Study length

about 3.8 years

Ages

18+

Locations

107 sites in AL, CA, CT +23

About this study

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.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Placebo
  • 2.Take empagliflozin
  • 3.Take vicadrostat
PhasePhase 3
Drugempagliflozin
Routeoral

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low12%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

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