FINEARTS-HF: Finerenone Helps Across Ejection Fraction Spectrum

Sep 06, 2024

Results from the FINEARTS-HF trial are expected to rewrite guidelines with data showing that the non-steroidal mineralocorticoid receptor agonist (MRA) finerenone significantly reduced the risk for cardiovascular death and heart failure (HF) events in patients with HF and mildly reduced or preserved ejection fraction (LVEF ≥40%). These results complement previous efficacy data in patients with reduced LVEF and patients with chronic kidney disease.

The cardiovascular and kidney-related benefits of finerenone in patients with reduced LVEF were recently demonstrated in two large clinical trials: FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049)^1,2. The FIGARO-DKD trial focused on cardiovascular outcomes, while the FIDELIO-DKD trial emphasized renal outcomes. Both trials showed that finerenone significantly reduced the risk for kidney failure, decreased the progression of albuminuria, and lowered the incidence of cardiovascular events.

Prof. Scott Solomon MD from the Brigham and Women’s Hospital, in MA, US, presented the results of the FINEARTS-HF trial (NCT04435626), which were simultaneously published in the New England Journal of Medicine^3,4. This phase 3, multicenter, randomized, double-blind trial involving 6,001 participants demonstrated that finerenone was associated with a 16% reduction in the composite outcome of cardiovascular death and total HF events compared with placebo (rate ratio 0.84; 95% CI 0.74–0.95; P=0.007). The trial also met secondary outcomes, including reduced total worsening HF events and improved patient-reported health status as measured by the Kansas City Cardiomyopathy Questionnaire.

The findings mark a significant advancement in the treatment of patients with heart failure with LVEF (≥40%), a group for whom effective and guideline-directed therapies have been limited. While finerenone was generally well-tolerated, increased levels of hyperkalaemia were noted, though these rarely led to hospitalization.

Prof. Solomon concluded by positioning finerenone “as a promising option for managing HF in patients with mildly reduced or preserved ejection fraction, addressing a critical need in cardiovascular care.” Further regulatory discussions and approvals are anticipated following these findings.