Heart failure & cardiomyopathiesMeta-analysis

Efficacy and Safety of Finerenone in Heart Failure With Preserved Ejection Fraction

JACC Heart FailPublished

  • Prespecified participant-level pooled analysis of the FIDELIO-DKD, FIGARO-DKD and FINEARTS-HF randomised trials (FINE-HEART)
  • Cox models stratified by trial

Authors' conclusion

This participant-level pooled analysis of 3 large-scale outcomes trials supports the use of finerenone in individuals with HFmrEF/HFpEF across a broad range of cardiovascular-kidney-metabolic risk.

Study context

Population
Participants with heart failure with mildly reduced ejection fraction (HFmrEF) or heart failure with preserved ejection fraction (HFpEF) from 3 finerenone outcomes trials (mean age 71 ± 10 years; 44% female)of 18,991 pooled, 3 trials
Participants
7,008 participants
Comparison
Finerenone vs placebo
Outcome
CV death or HF hospitalisation
Follow-up
Median 2.5 years

Pooled result

As reported in the abstract

Hazard ratio

0.87

95% CI 0.78–0.96

P = 0.008

Finerenone vs Placebo
HR 0.87 (95% CI 0.78–0.96); P = 0.008

Further pooled results

OutcomeHR (95% CI)P value
HF hospitalisation0.84 (0.74–0.94)P = 0.003
New-onset AF0.75 (0.58–0.97)P = 0.030

Primary endpoint by baseline eGFR, urine albumin-to-creatinine ratio, glycated haemoglobin (subgroups)

Consistent effects across key subgroups and baseline eGFR, UACR and HbA1c
  • eGFR Pinteraction = 0.47
  • UACR Pinteraction = 0.62
  • HbA1c Pinteraction = 0.93

CV death, all-cause death

No statistically significant decrease in CV death or all-cause death

Safety

Hyperkalaemia, hypokalaemia, serious adverse events

Hyperkalaemia more common with finerenone vs placebo
Hypokalaemia less common with finerenone vs placebo
Serious adverse events similar between arms

Original publication

Efficacy and Safety of Finerenone in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. Published 11 June 2025. doi:10.1016/j.jchf.2025.03.041

Summarised from the published abstract; every number is checked against it