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A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists

NCT06033950

RecruitingPhase 3

Sponsor: Colorado Prevention Center

Conditions: Heart Failure

Interventions: Finerenone, Placebo

Countries: United States, Argentina, Brazil, Canada, Croatia, Czechia, Greece, Hungary

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (176)

Fairhope, Alabama, United States
Phoenix, Arizona, United States
Yuma, Arizona, United States
Chula Vista, California, United States
Chula Vista, California, United States
Northridge, California, United States
Orange, California, United States
Pomona, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Sherman Oaks, California, United States
Tarzana, California, United States
Van Nuys, California, United States
West Covina, California, United States
West Hills, California, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Bradenton, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Peoria, Illinois, United States
Merrillville, Indiana, United States
Cynthiana, Kentucky, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
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