A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Fail
Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).
| Condition(s) | Heart Failure |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA). |
| Who can participate | Inclusion Criteria: * Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations * Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence * Symptomatic HFrEF per protocol defined criteria * Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment * Negative pregnancy test and agreement to use adequate contraception during trial (female participants only) Exclusion Criteria: * Treatment with non-steroidal MRA (nsMRA) * Documented prior history of severe hyperkalemia in the setting of MRA use * eGFR \< 25 mL/min/1.73m² and / or potassium \> 5.0 mmol/L * Acute myocardial infarction, coronary revascularization, valve replacement/rep |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Colorado Prevention Center |
| Locations | Fairhope, Alabama, United States; San Diego, California, United States; Kansas City, Missouri, United States; Austin, Texas, United States; Goiânia, Goiás, Brazil; Sao Paulp, Sap Paulo, Brazil (+2 more sites) |
| Start date | 2024-08-20 |
| NCT ID | NCT06033950 |
| Official listing | https://clinicaltrials.gov/study/NCT06033950 |