RecruitingHeart Failure

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

Eligible age

18+ yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About this study

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).

Sponsor: Colorado Prevention Center

You may qualify if…

✓ 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)

You may not qualify if…

✕ 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