Heart Failure
Conditions
Keywords
Reduced ejection fraction, Symptomatic heart failure
Brief 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).
Detailed description
This is an international, randomized, double-blind, placebo-controlled trial of finerenone for the treatment of heart failure patients with reduced ejection fraction.
Interventions
DRUGFinerenone
Oral finerenone.
DRUGPlacebo
Matching oral placebo.
Sponsors
Colorado Prevention Center
St. Luke's Hospital, Kansas City, Missouri
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned * Prior or planned heart transplant * Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure * Symptomatic bradycardia or second- or third-degree heart block without a pacemaker * Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction * Probable alternative cause of participant's HF * Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers * Known hypersensitivity to the IP (active substance or excipients) * Any other condition or therapy which would make the participant unsuitable for the study * Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first occurrence of cardiovascular (CV) death or HF event. | Ongoing, up to ~30 months | \- Time to first CV death or HF event with finerenone compared to placebo. |
| Number of serious adverse events | Ongoing, up to ~30 months | \- Serious adverse events (excluding efficacy endpoints) with finerenone compared to placebo. |
| Number of adverse events leading to discontinuation of study drug. | Ongoing, up to ~30 months | \- Number of adverse events leading to discontinuation of investigational product with finerenone compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timing and occurrence of total CV deaths and HF events | Ongoing, up to ~30 months | \- 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 | Ongoing, up to ~30 months | 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. | 180 days | \- Change in KCCQ-TSS with finerenone compared to placebo. |
| Time to CV death. | Ongoing, up to ~30 months | \- Time to CV death with finerenone compared to placebo. |
| Time to all-cause death. | Ongoing, up to ~30 months | \- Time to all-cause mortality with finerenone compared to placebo. |
Countries
Argentina, Brazil, Canada, Croatia, Czechia, Greece, Hungary, Italy, Japan, Poland, Spain, Sri Lanka, United Kingdom, United States
Contacts
CONTACTMarc Bonaca
Outcome results
None listed