Finerenone Benefits Heart Failure Patients Regardless of Frailty Status: JAMA

Frailty is often a concern when introducing novel therapies in HF patients, as it is typically linked with poorer outcomes and increased vulnerability to adverse events. This research evaluated whether frailty influences the safety and effectiveness of finerenone in individuals with HFmrEF or HFpEF.

The prespecified secondary analysis drew on data from the phase 3 FINEARTS-HF randomized clinical trial, conducted across 653 sites in 37 countries. The study enrolled patients with NYHA class II-IV HF, left ventricular ejection fraction of 40% or higher, structural heart disease, and elevated natriuretic peptide levels. Participants were randomized to receive either once-daily finerenone or placebo in addition to standard therapy. The primary endpoint was a composite of cardiovascular death and total worsening HF events. Frailty was assessed using the Rockwood cumulative deficit model.

The study led to the following findings:

• Among 6,001 patients enrolled, frailty data were available for 5,952 participants (mean age 72 years; 54.4% male).
• 26.7% of patients were classified as not frail, 36.0% as moderately frail, and 37.3% as most frail.
• Higher frailty levels were associated with worse clinical outcomes, including increased risks of cardiovascular death and heart failure events.
• Finerenone reduced the risk of cardiovascular death and worsening heart failure events across all frailty groups.
• Finerenone improved symptom scores in patients regardless of frailty status.
• The treatment effects of finerenone did not significantly vary by level of frailty.
• The incidence of common adverse events—including hypotension, kidney dysfunction, and electrolyte imbalances—was similar across all frailty groups.

These findings suggest that finerenone maintains a favorable benefit-risk profile even in frail patients, a population often overlooked in HF treatment due to safety concerns. The results advocate for broader consideration of finerenone use in clinical practice, particularly for frail patients who may still benefit from the therapy.

While the study is limited by the underrepresentation of the most frail patients, typically excluded from clinical trials, and the absence of certain frailty measures, such as muscle strength, it provides compelling evidence for the utility of finerenone in a real-world HF population.

The authors concluded, "finerenone appears to be an effective and safe option for managing HFmrEF and HFpEF, irrespective of a patient’s frailty status. These findings should encourage clinicians to consider its use even in frail individuals, helping to optimize care for this vulnerable patient group."

Reference:

Butt JH, Jhund PS, Henderson AD, et al. Finerenone According to Frailty in Heart Failure: A Prespecified Analysis of the FINEARTS-HF Randomized Clinical Trial. JAMA Cardiol. Published online June 18, 2025. doi:10.1001/jamacardio.2025.1775