Finerenone and New York Heart Association Functional Class in Heart Failure: The FINEARTS-HF Trial

Background: The NYHA functional classification remains an important and widely used metric in heart failure (HF)-oriented clinical care and research. Objectives: This study aims to evaluate whether the effect of finerenone varies according to NYHA functional class in HF with mildly reduced or preserved ejection fraction. Methods: In this prespecified analysis of the FINEARTS-HF trial, treatment effects of finerenone according to baseline NYHA functional class (II or III/IV) were examined on the primary endpoint (cardiovascular death and total HF events) and key secondary endpoints. Effects of finerenone on change in NYHA functional class were evaluated using ordinal logistic regression. Results: At baseline, 4,146 (69%) and 1,854 (31%) participants were NYHA functional class II and III/IV, respectively. Participants with baseline NYHA functional class III/IV vs II experienced a significantly higher rate of cardiovascular death and total HF events (adjusted rate ratio: 1.28 [95% CI: 1.11-1.46]; P < 0.001). Finerenone consistently reduced the primary endpoint irrespective of baseline NYHA functional class (Pinteraction = 0.54), with greater absolute benefits in NYHA functional class III/IV (absolute rate reduction [ARR]: 4.5 per 100 person-years) vs II (ARR: 2.0 per 100 person-years). Benefits of finerenone on Kansas City Cardiomyopathy Questionnaire–Total Symptom Score at 12 months were consistent irrespective of NYHA functional class (Pinteraction = 0.93). NYHA functional class improved similarly in the finerenone and placebo arms out to 12 months. The safety profile of finerenone was similar among participants with baseline NYHA functional class III/IV vs II. Conclusions: In this FINEARTS-HF analysis, finerenone reduced clinical outcomes and improved patient-reported health status in HF with mildly reduced or preserved ejection fraction irrespective of baseline NYHA functional class. (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with Heart Failure [FINEARTS-HF]; NCT04435626)