FINERENONE is safe and effective in reducing heart failure events and cardiovascular deaths in patients with mildly reduced or preserved ejection fraction, regardless of frailty status, according to the results of the the FINEARTS-HF trial.
Frailty is common in patients with heart failure with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), and is often associated with poorer health outcomes and reluctance to introduce new therapies. However, determining whether treatments such as finerenone are beneficial and safe across the spectrum of frailty is crucial for optimising care in this vulnerable population.
This prespecified secondary analysis of the phase 3 FINEARTS-HF trial included 6001 patients randomised to receive either once-daily finerenone or placebo in addition to standard therapy, across 653 sites in 37 countries. A frailty index (FI) was calculated for 5952 participants (mean age 72.0 years; 54.4% male), categorising them as not frail (class I, 26.7%), more frail (class II, 36.0%), or most frail (class III, 37.3%). Patients with greater frailty had substantially higher risks of the primary composite outcome—cardiovascular death and worsening heart failure events—compared to those who were not frail (rate ratio [RR] 1.88 for class II and 3.86 for class III versus class I). Importantly, the benefit of finerenone was consistent across all frailty classes, with no significant interaction between frailty and treatment effect (P for interaction = .77). The reduction in risk for the primary outcome with finerenone compared to placebo was observed in class II (RR 0.66, 95% CI 0.52-0.83), and similar trends were seen in other frailty groups. Finerenone also improved symptoms, as measured by the Kansas City Cardiomyopathy Questionnaire, and the rates of adverse events such as hypotension, hyperkalaemia, or changes in creatinine did not differ by frailty status.
These findings have important implications for clinical practice, challenging the notion that frail patients should be excluded from novel heart failure therapies. Clinicians should feel confident prescribing finerenone to patients with HFmrEF or HFpEF, regardless of frailty, as the benefit-risk profile remains favourable across the spectrum. Future research should focus on further personalising heart failure therapy and understanding how best to support frail patients in real-world settings, but current evidence supports broad use of finerenone in this population to improve outcomes and quality of life.
Reference
Butt JH et al. Finerenone According to Frailty in Heart Failure: A Prespecified Analysis of the FINEARTS-HF Randomized Clinical Trial. JAMA Cardiol. 2025;DOI:10.1001/jamacardio.2025.1775.
