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).
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
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/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned
Parallel
Finerenone
DrugOral finerenone.
Placebo
DrugMatching oral placebo.
Time to first occurrence of cardiovascular (CV) death or HF event.
\- Time to first CV death or HF event with finerenone compared to placebo.
Number of serious adverse events
\- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo.
Number of adverse events leading to discontinuation of study drug.
\- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo.
Timing and occurrence of total CV deaths and HF events
\- Timing and occurrence of total (first and subsequent) events of CV death and HF events and CV deaths with finerenone compared to placebo.
Timing and occurrence of total HF events
Timing and occurrence of total (first and recurrent) HF events with finerenone compared to placebo.
Change in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) from baseline to Month 6.
\- Change in KCCQ-TSS with finerenone compared to placebo.
Time to CV death.
\- Time to CV death with finerenone compared to placebo.
Click on the lead sponsor to view all of their trials.
Colorado Prevention Center
Lead sponsor
St. Luke's Hospital, Kansas City, Missouri
Collaborator
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Collaborator
