A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients

Launched by COLORADO PREVENTION CENTER · Aug 15, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called Finerenone to see if it can help improve the health and survival of patients who are hospitalized with acute heart failure. Heart failure is a condition where the heart doesn’t pump blood as well as it should, and this study is looking specifically at patients whose heart function is mildly reduced or normal. Participants in the trial will receive either Finerenone or a placebo (a harmless pill with no active medication) to compare how well the treatment works.

To be eligible for this study, participants need to be at least 18 years old, currently hospitalized for heart failure, and show specific signs of the condition. They must also have certain levels of heart-related markers in their blood. However, individuals who have certain other health issues or are taking specific medications will not be able to participate. Those who join the trial can expect regular check-ins to monitor their health and any effects of the medication, helping researchers determine if Finerenone is a safe and effective treatment for heart failure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provide electronic or written informed consent, either personally or through a legally authorized representative
• • Age ≥18 years
• • Current hospitalization or recently discharged with the primary diagnosis of heart failure
• • Heart failure signs and symptoms at the time of hospital admission
• • Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
• • Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF
• Exclusion Criteria:
• • Treatment with a mineralocorticoid receptor antagonist (MRA)
• • Documented prior history of severe hyperkalemia in the setting of MRA use
• • Estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m² or serum/plasma potassium \>5.0 mmol/L at screening
• • Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
• • Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
• • Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or known pericardial constriction
• • Probable alternative cause of participant's heart failure symptoms
• • Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers