Research AppraisalRandomised Controlled Trial

Efficacy of finerenone in patients with heart failure and mildly reduced or preserved ejection fraction: a prespecified analysis of heart rate and heart rhythm in the FINEARTS-HF trial

European journal of heart failureChimura, Misato, Jhund, Pardeep S, Henderson, Alasdair D et al.2 May 2026DOI

Clinical Snapshot

80CEBM
Evidence: ModerateRandomised Controlled Trial

PICO Framework

P — PopulationPatients with heart failure and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF), stratified by heart rhythm (sinus rhythm n=3497, atrial fibrillation n=2190)
I — InterventionFinerenone (mineralocorticoid receptor antagonist)
C — ComparatorPlacebo
O — OutcomesPrimary: composite of cardiovascular death and total heart failure events; Secondary: heart rate changes from baseline to 12 months

Bottom Line

This prespecified analysis of FINEARTS-HF demonstrates that finerenone's cardiovascular benefits in HFpEF/HFmrEF patients are consistent across the heart rate spectrum, regardless of underlying rhythm. Importantly, higher baseline heart rate predicted worse outcomes in patients with sinus rhythm but not in those with atrial fibrillation, suggesting different pathophysiological mechanisms. While finerenone produced a statistically significant but small heart rate reduction (1.35 bpm) in AF patients, the clinical significance remains uncertain. The findings support finerenone use across diverse heart rate presentations in HFpEF/HFmrEF, though clinicians should consider that heart rate may be a more important prognostic marker in patients maintaining sinus rhythm. This analysis reinforces the broad applicability of finerenone's benefits in this challenging patient population.

Evidence: Moderate

Key Findings

  • P Value: P for interaction = 0.96 in sinus rhythm; 0.49 in atrial fibrillation

  • Effect Size: Consistent effect of finerenone across heart rate spectrum, regardless of rhythm

  • Primary Outcome: Composite of cardiovascular death and total heart failure events

  • Nnt Or Sensitivity: Heart rate reduction of 1.35 bpm in atrial fibrillation patients (placebo-corrected)

  • Confidence Interval: 95% CI: 0.41-2.29 bpm for heart rate reduction in AF patients

Clinical Application

Finerenone is available and the heart rhythm stratification is easily determined from standard ECG in clinical practice Relevant to Australian cardiology and general practice given high prevalence of HFpEF/HFmrEF. TGA approval status and PBS listing would determine accessibility. Aligns with current RACGP heart failure management guidelines Patients with HFpEF/HFmrEF in Australian practice, particularly those with atrial fibrillation where modest heart rate reduction may provide additional benefit

Abstract

AIMS: The association between heart rate (HR) and clinical outcomes is well understood in patients with heart failure with reduced ejection fraction (HFrEF) but less clear in those with HFmrEF/HFpEF, especially among individuals with atrial fibrillation (AF). In a prespecified analysis of the FINEARTS-HF trial, we examined the association between baseline HR and clinical outcomes by heart rhythm and evaluated finerenone's effect across the spectrum of HR. METHODS: The primary outcome was a composite of cardiovascular death and total (first and recurrent) HF events. Heart rhythm (sinus rhythm or AF) was determined from the baseline ECG. Patients with pacemaker rhythm or missing HR/rhythm data were excluded. RESULTS: Among patients with sinus rhythm (SR n = 3497; 62%), higher baseline HR was associated with a higher incidence rate for the primary outcome. In patients with AF (n = 2190; 38%), no association between HR and outcomes was observed. The effect of finerenone on the primary outcome was consistent across the HR spectrum, regardless of rhythm (P for interaction = 0.96 in SR; 0.49 in AF). In patients with SR, there was no significant HR change with finerenone versus placebo. In AF patients, finerenone led to a small but statistically significant HR reduction: a placebo-corrected decrease of 1.35 bpm (95% CI: 0.41-2.29) from baseline to 12 months. CONCLUSIONS: Among patients with HFpEF/HFmrEF in FINEARTS-HF, higher baseline HR was associated with a higher risk of the primary outcome in patients with SR but not in those with AF. Finerenone's effect on the primary outcome was consistent across the HR spectrum, irrespective of rhythm. TRIAL REGISTRATION: ClinicalTrials.gov NCT04435626.

References

  1. 1.Chimura, M., Jhund, P. S., Henderson, A. D., Claggett, B. L., Desai, A. S., Lay-Flurrie, J., Scalise, A., Rohwedder, K., Lam, C. S. P., Senni, M., Zannad, F., Pitt, B., Vaduganathan, M., Solomon, S. D., & McMurray, J. J. V. (2026). Efficacy of finerenone in patients with heart failure and mildly reduced or preserved ejection fraction: a prespecified analysis of heart rate and heart rhythm in the FINEARTS-HF trial. European Journal of Heart Failure. https://doi.org/10.1093/ejhf/xuag008
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