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
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