Heart failure & cardiomyopathies
Efficacy and Safety of Finerenone in Heart Failure With Preserved Ejection Fraction: A FINE-HEART Analysis
Pooled result · CV death or HF hospitalisationResult — go to the resultHazard ratio 0.87 95% CI 0.78–0.96Authors' 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
Methodological detailsFINE-HEART, Cox models stratified by trial
- FINE-HEART
- Cox models stratified by trial
Pooled result
CV death or HF hospitalisation
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
As reported in the abstract
Further pooled results
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| HF hospitalisation | 0.84 (0.74–0.94) | P = 0.003 | |
| New-onset AF | 0.75 (0.58–0.97) | P = 0.030 | |
| 0.512Hazard ratio (log scale) |
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: A FINE-HEART Analysis. JACC Heart Fail. Published 11 June 2025. doi:10.
Summarised from the published abstract; every number is checked against it