1. In this randomized controlled trial of patients with heart failure and mildly decreased or preserved ejection fraction, finerenone treatment was associated with lower rates of worsening heart failure events. 

2. Finerenone treatment was not associated with an increase in serious adverse events.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, has been shown to improve cardiovascular outcomes in patients with concurrent chronic kidney disease and type two diabetes mellitus. This study therefore aimed to evaluate whether adding finerenone to standard therapies for heart failure with mildly reduced or preserved ejection fraction could mitigate cardiovascular deterioration, thereby reducing heart failure events and mortality. The results indicated that patients treated with finerenone experienced significantly fewer worsening heart failure events than those assigned to placebo. However, there was no observed difference in cardiovascular-related deaths between the groups. Patients receiving finerenone also reported significant improvements in symptoms and physical limitations, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). No difference was observed between the groups using the New York Heart Association (NYHA) classification. There were no significant differences between the treatment groups in overall mortality or kidney composite outcomes. In addition, no significant differences in serious adverse events were found between the groups. Notable limitations of the study include limited enrollment of Black patients, insufficient power in subgroup analyses, and limited generalizability of findings to other mineralocorticoid receptor antagonists. Despite these limitations, the findings suggest that finerenone treatment in patients with heart failure and mildly reduced or preserved ejection fraction may decrease the frequency of worsening heart failure events.

Click here to read the study in NEJM

In-Depth [randomized controlled trial]: This randomized controlled trial evaluated the efficacy and safety of finerenone for treating heart failure with mildly reduced or preserved ejection fraction. Study inclusion criteria required participants to be over 40 years old, have symptomatic heart failure with a ventricular ejection fraction of 40% or higher, demonstrate structural heart disease, and have elevated natriuretic peptide levels. Following randomization, 3,003 patients received finerenone and 2,998 received a placebo. The primary outcome was a composite measure of worsening heart failure events (defined as urgent hospitalization or heart failure-related visits) and cardiovascular death. Finerenone significantly reduced the composite outcome, with 1,083 events in the finerenone group compared to 1,283 events in the placebo group (rate ratio [RR], 0.84; 95% Confidence Interval [CI], 0.74–0.95; p=0.007). However, no significant difference was found between groups when death from cardiovascular causes was assessed independently (RR, 0.93; 95% CI, 0.78–1.11). Finerenone treatment was associated with a notable reduction in symptom burden as measured by the KCCQ (RR, 1.6; 95% CI, 0.80–2.30; p<0.001), but no difference was observed with the NYHA classification (RR, 1.01; 95% CI, 0.88–1.15). There were also no significant differences in kidney composite outcomes (RR, 1.33; 95% CI, 0.94–1.89) or all-cause mortality (RR, 0.93; 95% CI, 0.83–1.06). Notably, finerenone did not increase serious adverse events, with 38.7% in the finerenone group and 40.5% in the placebo group experiencing such events. In summary, these findings indicate that finerenone is a potentially effective and safe treatment for heart failure patients with mildly reduced or preserved ejection fraction.

Image: PD

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