Audience: heart-failure clinicians, trainees and evidence-based-medicine readers. Evidence reviewed: September 2026.
Bottom line
FINEARTS-HF showed that finerenone reduced the rate of the composite of total worsening heart-failure events and cardiovascular death in symptomatic heart failure with left-ventricular ejection fraction (LVEF) ≥40%. The benefit was driven mainly by fewer worsening heart-failure events, with more hyperkalaemia but less hypokalaemia.
Clinical question
Does the non-steroidal mineralocorticoid-receptor antagonist finerenone improve outcomes in patients with heart failure and mildly reduced or preserved ejection fraction?
Design and population
FINEARTS-HF was an international, double-blind, randomised, placebo-controlled trial. It enrolled 6,001 patients aged 40 years or older with symptomatic heart failure, LVEF ≥40%, structural heart disease and elevated natriuretic peptides. Participants received finerenone or placebo in addition to usual therapy. The primary endpoint was a recurrent-event composite: total worsening heart-failure events plus cardiovascular death.
| Feature | Why it matters |
|---|---|
| Recurrent-event analysis | Counts first and subsequent worsening-HF events rather than only time to first event. |
| LVEF ≥40% | Addresses HFmrEF/HFpEF, where evidence for steroidal MRAs had been uncertain. |
| Biomarker and structural criteria | Enriched the population for objectively supported heart failure. |
| Active contemporary background care | Improves relevance, although uptake of some newer therapies varied. |
Results
During a median follow-up of 32 months, 1,083 primary-outcome events occurred in the finerenone group and 1,283 in the placebo group. The rate ratio was 0.84 (95% confidence interval 0.74–0.95; P=0.007). Worsening heart-failure events numbered 842 versus 1,024 (rate ratio 0.82, 95% CI 0.71–0.94). Cardiovascular death occurred in 8.1% versus 8.7% of participants; the trial did not demonstrate a clear mortality reduction.
Treatment effects were broadly consistent across prespecified subgroups, including the range of LVEF studied. Finerenone increased creatinine and hyperkalaemia risk but reduced hypokalaemia. The clinical trade-off therefore includes renal-function and potassium surveillance.
Strengths and limitations
- Strengths: large randomised design, blinded outcome assessment, broad geography and clinically meaningful recurrent-event endpoint.
- Endpoint interpretation: the primary benefit was morbidity rather than proven cardiovascular survival.
- Generalisability: trial eligibility and monitoring may not represent frail patients, advanced kidney disease or routine-care adherence.
- Background therapy: evolving SGLT2-inhibitor use complicates direct extrapolation to every present-day regimen.
Clinical application
Finerenone is a disease-modifying option for appropriately selected patients with HFmrEF/HFpEF, particularly when recurrent decompensation risk is important. Before initiation, confirm the indication, estimated glomerular filtration rate, serum potassium, interacting medicines and the ability to repeat blood tests. Do not assume interchangeability with spironolactone or eplerenone: molecular properties, evidence bases and licensed indications differ.
Selected references
- Solomon SD et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2024.
- FINEARTS-HF primary publication.
- 2026 ESC guideline for acute and chronic heart failure.
Educational critical appraisal only. Prescribing must follow the current licence, formulary, renal/potassium criteria and local heart-failure pathways.