FINEARTS-HF: Finerenone improves outcomes in heart failure with preserved ejection fraction

The results of the FINEARTS-HF trial show that the non-steroidal mineralocorticoid receptor agonist (MRA) finerenone significantly reduced the risk of 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 2 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 emphasised renal outcomes. Both trials showed that finerenone significantly reduced the risk of kidney failure, decreased the progression of albuminuria, and lowered the incidence of cardiovascular events.

Prof. Scott Solomon (Brigham and Women's Hospital, MA, USA) presented the results of the  FINEARTS-HF trial (NCT04435626), which were simultaneously published in the New England Journal of Medicine [3,4]. This multicentre, randomised, double-blind, phase 3 trial involving 6,001 participants demonstrated that finerenone reduced the composite outcome of cardiovascular death and total HF events compared with placebo by 16% (rate ratio 0.84; 95% CI 0.74–0.95; P=0.007; see Figure). 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.

Figure: FINEARTS-HF primary endpoint – CV death and total HF events [4]



CV, cardiovascular; HF, heart failure; pt-yrs, patient-years.

The findings mark a significant advancement in the treatment of patients with HF with LVEF ≥40%, a group for whom effective, guideline-directed therapies have been limited. While finerenone was generally well tolerated, increased levels of hyperkalaemia were noted, though these rarely led to hospitalisation. Rates of hypokalemia were significantly lower with finerenone.

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.

Relevant readings:

• MRAs show varied efficacy  in heart failure across ejection fractions (ESC 2024)
• Application of guideline-directed medical therapy in patients with HFrEF in the Netherlands (HFA 2024)
• Antagonising the mineralocorticoid receptor beneficial for patients with diabetes and CKD (ESC 2021)
• Finerenone reduces the risk of AF onset in patients with CKD and diabetes (ACC 2021)

 

1. 
   
   1. Bakris GL, et al. N Engl J Med 2020;383(23):2219-2229.
   2. Pitt B, et al. N Engl J Med 2021;385(24):2252-2263.
   3. Solomon S, et al. N Engl J Med 2024;391:1475-1485.
   4. Solomon S, et al. FINEARTS-HF – Finerenone in heart failure with mildly reduced and preserved ejection fraction. HOTLINE 7, ESC Congress 2024, 30 Aug–02 Sept, London, UK.

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Posted on 7 November 20247 November 2024