Finerenone in patients with severe heart failure: the FINEARTS-HF Trial

Abstract Background While patients with severe heart failure (HF) were historically considered to have reduced left ventricular ejection fraction (LVEF), it is increasingly recognized that severe HF exists regardless of LVEF, with patients experiencing debilitating clinical symptoms and worse cardiovascular (CV) outcomes. The early identification of severe HF is important for prompt specialty referral and consideration of therapeutic escalation. Purpose To assess the prevalence, CV outcome risk, and treatment response to the nonsteroidal mineralocorticoid receptor antagonist finerenone among patients with severe HF as defined by the adapted ESC-HFA definition (NYHA class III/IV, HF diagnosis, at least one HF hospitalization with the past 12 months, and impaired quality of life (KCCQ-TSS < 75)). Methods FINEARTS-HF was a randomized, double-blind, clinical trial testing finerenone against placebo in patients with HF and LVEF ≥40%. Treatment effects of finerenone on the primary endpoint of total (first and recurrent) worsening HF events and CV death were assessed by severe HF status. Results Overall, 888 (15%) fulfilled the adapted ESC-HFA definition for severe HF. Patients with severe HF were older, with a higher comorbidity burden, and higher levels of NT-proBNP. Over a median follow-up of 2.7 years, total worsening HF events and CV death occurred at a rate of 32 per 100py (622 events) among those with severe HF, which was approximately twice as high as those without severe HF (adjusted rate ratio 2.24, 95% confidence interval 1.93-2.60). Treatment with finerenone was consistently beneficial in reducing the risk of the primary endpoint regardless of the severe HF status (Pinteraction=0.98, Figure 1). In light of higher baseline risk, the absolute rate reduction with finerenone appeared greater in those with severe HF (5.9 per 100py) compared with those without severe HF (2.2 per 100py). The proportions of patients who discontinued study treatment for any reason or experienced adverse events according to treatment assignment were similar regardless of severe HF status. Conclusions In a large, global contemporary HF trial population with mildly reduced or preserved EF, "guidelines-defined severe HF" was associated with a heightened risk of CV events. Treatment with the nonsteroidal mineralocorticoid receptor antagonist finerenone appeared safe and effective in reducing the risk of worsening HF events or CV death, even in those with greater severity of HF.Figure 1.