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

Boehringer Ingelheim
NCT IDNCT06424288ClinicalTrials.gov data as of Apr 2026
Phase

Phase 3

Target enrollment

6,000

Study length

about 3.9 years

Ages

18+

Locations

94 sites in AL, CA, CT +27

About this study

This trial is testing whether vicadrostat, taken with empagliflozin, helps people with heart failure. Participants will be randomly assigned to take either vicadrostat/empagliflozin or a placebo/empagliflozin once daily for 1435 days. Doctors will regularly check participants' health and monitor any side effects.

Based on ClinicalTrials.gov records.

What participants do

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

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low15%
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 chance from baseline in diastolic blood pressure (DBP) [mmHg] at Week 32 in participants with baseline DBP ≥80 mmHg, Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32, Absolute change from baseline in KCCQ-OSS at Week 32, Absolute change from baseline in KCCQ-OSS at Week 52, Absolute change from baseline in KCCQ-TSS at Week 52, 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% eGFR from baseline** or onset of sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m2 (composite renal endpoint)

Body systems

Cardiology / Heart