Finerenone Across the CKM Spectrum: FINE-HEART A participant-level pooled analysis of 18,991 adults with CKM conditions

Authors

  • Dr. Pallavi Mishra, MBBS, MD (Medicine), KGMU M.Sc Cardiology, South Wales Diabeteto -Cardiologist Women cardiologist Echocardiography Specialist English Author

Keywords:

Finerenone, FINE‑HEART pooled analysis, CKM syndrome, Nonsteroidal mineralocorticoid receptor antagonist, Cardiorenal outcomes, Atrial fibrillation

Abstract

Abstract 
Background: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, has demonstrated kidney and cardiovascular benefits in individual trials of patients with diabetic kidney disease and heart failure. FINE‑HEART pooled participant‑level data from FIDELIO‑DKD, FIGARO‑DKD, and FINEARTS‑HF to evaluate finerenone’s effects across the full CKM spectrum.

Methods and population: The analysis combined 18,991 adults with CKM conditions followed for a median of 2.9 years. Participants were staged using an adapted CKM framework to permit stage‑specific inference. Prespecified outcomes included all‑cause mortality, all‑cause hospitalization, heart‑failure hospitalization, a composite kidney outcome, and new‑onset atrial fibrillation. A cancer‑history subanalysis examined safety and efficacy among participants with prior malignancy (n=1,389).

Results: Finerenone treatment was associated with reductions in all‑cause mortality, all‑cause and heart‑failure hospitalizations, the composite kidney endpoint, and incidence of new‑onset atrial fibrillation. The magnitude of benefit was observable across CKM stages, enabling clinicians to interpret effect sizes by disease severity. In participants with a history of cancer, finerenone showed consistent efficacy and no signal for increased cancer incidence or cancer‑related mortality.

Conclusions: FINE‑HEART offers robust, participant‑level evidence that finerenone delivers multiorgan protection across the CKM spectrum, supporting its guideline role as add‑on therapy for persistent albuminuria and combined cardiorenal risk. The pooled design increases power to detect less frequent but clinically relevant outcomes and reduces uncertainty for real‑world prescribing, including among patients with prior malignancy.

NEWSLETTER 9 Finerenone Across the CKM Spectrum: FINE-HEART A participant-level pooled analysis of 18,991 adults with CKM conditions Figure 9. Finerenone Across the CKM Spectrum: FINE-HEART — mechanism overview (illustrative; labels added for education). FINE-HEART is a participant-level pooled analysis combining three phase 3 trials—FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF—totalling 18,991 adults with CKM conditions, and it has become a reference dataset for understanding finerenone across the syndrome.1 Over a median follow-up of 2.9 years, finerenone reduced the risk of all-cause mortality, all-cause hospitalisation, heart-failure hospitalisation, the composite kidney outcome, and new-onset atrial fibrillation.1 The breadth of those endpoints is important: a single nonsteroidal mineralocorticoid receptor antagonist shows benefit across all three CKM axes, supporting its guideline role as add-on therapy when albuminuria persists.6 A 2026 cancer-history subanalysis addressed a common real-world concern. Among the 18,991 participants, 1,389 (7.3%) had a baseline history of cancer, and finerenone’s efficacy and safety were consistent regardless of cancer history.1 Reassuringly, the treatment effect on cancer death (subdistribution HR 0.81, 95% CI 0.64–1.03) and on de novo cancer incidence (HR 0.92, 95% CI 0.79–1.06) showed no adverse cancer signal.1 For clinicians managing patients with prior malignancy—an increasingly common scenario—this removes a potential barrier to prescribing. The population is well characterised across the syndrome. FINE-HEART participants were classified into CKM Stages 2–4 using an adapted 2023 AHA framework, with mean age ranging 67.0–69.3 years and 34.2–35.1% women.2 This staging allows the benefits to be interpreted stage by stage rather than as a single averaged effect. The pooled design is itself a strength. By combining three large trials that spanned diabetic kidney disease and heart failure, FINE-HEART assembled enough events to examine outcomes—such as new-onset atrial fibrillation and the composite kidney endpoint—that individual trials were underpowered to resolve.1 Interpreting those results through CKM Stages 2–4 rather than as a single averaged effect lets clinicians see how benefit tracks with disease severity, and corroborating datasets like INFINITY and the Lancet CKD pooled analysis reinforce the consistency of finerenone’s effect.3,4 Finerenone is one of the nonsteroidal MRA therapies highlighted in the 2026 CKM guideline for combined kidney and cardiovascular protection, and FINE-HEART supplies the pooled, participant-level evidence underpinning that recommendation.6 For practitioners, the analysis reinforces finerenone as a versatile agent whose benefits—and reassuring safety—extend across the diverse patients who define CKM syndrome. References 1. Finerenone in CKM syndrome and history of cancer: FINE-HEART pooled analysis, Eur J Heart Fail, June 29, 2026. https://academic.oup.com/eurjhf/article/28/Supplement_2/xuag193.1363/8721035 2. Finerenone May Cut Sudden Death Risk Across the CKM Spectrum, Medscape, June 16, 2026. https://www.medscape.com/viewarticle/finerenone-may-cut-risk-sudden-death-across-ckm-spectrum-2026a1000kau 3. Bayer's INFINITY Analysis Shows Finerenone Delivers Long-Term Kidney and Heart Protection, Clival, June 9, 2026. https://clival.com/news/bayers-infinity-analysis-shows-finerenone-delivers-long-term-kidney-and-heart-protection-in-chronic-kidney-disease 4. Efficacy and safety of finerenone in CKD (pooled analysis), Lancet, June 13, 2026 (PMID 42248158). https://pubmed.ncbi.nlm.nih.gov/42248158/ 5. 2026 CKM Guideline — Top Things to Know, professional.heart.org, June 9, 2026. https://professional.heart.org/en/science-news/2026-guideline-for-the-prevention-detection-evaluation-and-management-of-ckm-syndrome/top-things-to-know 6. New guideline reframes weight as health risk, AHA Newsroom, June 9, 2026. https://newsroom.heart.org/news/new-guideline-reframes-weight-as-health-risk-tied-to-diabetes-kidney-and-heart-conditions

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Published

2026-07-07

Issue

Vol. 4 No. 9 (2029): Finerenone Across the CKM Spectrum: FINE-HEART A participant-level pooled analysis of 18,991 adults with CKM conditions

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Articles

How to Cite

Finerenone Across the CKM Spectrum: FINE-HEART A participant-level pooled analysis of 18,991 adults with CKM conditions. (2026). Diabzen, 4(9), 18-19. https://thediabzen.com/index.php/d/article/view/49

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