A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Phase 3
6,000
about 3.9 years
18+
94 sites in AL, CA, CT +27
Why this study is shown
What this study is about
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.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take empagliflozin
- 2.Take placebo
- 3.Take vicadrostat
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
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.
empagliflozin (SGLT2 inhibitor; increases glucose excretion in urine)
oral (Oral Tablet)
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)
Cardiology / Heart