Trial results for a Phase 3 study (NCT04435626) investigating finerenone in participants with heart failure and left ventricular ejection fraction greater or equal to 40% were posted on ClinicalTrials.gov on 2025-08-26. The study demonstrated that finerenone reduced the occurrence of the composite endpoint of cardiovascular death and total heart failure events with a rate ratio of 0.84 compared to placebo.
Background
The study aimed to evaluate the efficacy and safety of finerenone in participants with heart failure and left ventricular ejection fraction (LVEF) greater or equal to 40%.
Trial design
The study (NCT04435626) was a Phase 3, randomized, placebo-controlled trial that enrolled 6016 participants. The trial investigated finerenone compared to placebo in patients with Heart Failure and an ejection fraction greater than or equal to 40%. The primary objective was to evaluate the effect of finerenone in reducing cardiovascular death and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF.
Key results
The trial results showed several key findings:
- For the composite endpoint of cardiovascular death and total (first and recurrent) heart failure events, the finerenone group reported 1083 events (in 624 participants) compared to 1283 events (in 719 participants) in the placebo group. Analysis using a stratified Andersen-Gill model yielded a rate ratio (Finerenone/Placebo) of 0.84 (95% Confidence Interval: 0.74 to 0.95), with a p-value of 0.0072.
- Regarding total (first and recurrent) heart failure events, the finerenone group had 842 events (in 479 participants) compared to 1024 events (in 573 participants) in the placebo group. The stratified Andersen-Gill model analysis reported a rate ratio (Finerenone/Placebo) of 0.82 (95% Confidence Interval: 0.71 to 0.94), with a p-value of 0.0062.
- For the change from baseline in the Total Symptom Score (TSS) of the Kansas City Cardiomyopathy Questionnaire (KCCQ), the least squares mean was 7.99 for the finerenone group and 6.43 for the placebo group. A Mixed Models Analysis showed a difference in LS Mean of 1.56 (95% Confidence Interval: 0.79 to 2.34), with a p-value of 0.0001, indicating symptomatic improvement with finerenone.
- The proportion of participants who showed improvement in NYHA Class was 0.179 for finerenone and 0.178 for placebo. Logistic regression analysis showed an Odds Ratio (OR) of 1.01 (95% Confidence Interval: 0.88 to 1.15) with a p-value of 0.9295, indicating no significant difference between groups for this outcome.
What this means
The results indicate that finerenone significantly reduced the risk of cardiovascular death and total heart failure events in patients with heart failure and left ventricular ejection fraction greater or equal to 40%. The observed improvement in KCCQ symptom scores also suggests a benefit in patient-reported quality of life. These findings support the potential of finerenone as a therapeutic option for this specific heart failure population, although no significant difference was observed in the proportion of participants showing improvement in NYHA class.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04435626, titled "Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%)," were posted on 2025-08-26 on clinicaltrials.gov.