Effects of Finerenone on Sudden Death Across the Cardio-Kidney-Metabolic Landscape: A FINE-HEART Analysis.

Summary

A prespecified pooled participant-level analysis across 3 Phase III finerenone trials (n=18,991) found that finerenone reduced adjudicated sudden death (HR 0.81) over a median 2.9 years, with consistent effects across CKM subgroups. Key independent predictors of sudden death included older age, heart failure, atrial fibrillation, prior MI, higher UACR, and lower systolic blood pressure.

Key Findings

• Across 18,991 participants, finerenone reduced adjudicated sudden death vs placebo (HR 0.81; 95% CI 0.67-0.98).
• Sudden death incidence was higher in FINEARTS-HF than in CKD trials (1.5 vs 0.5 per 100 patient-years).
• Independent predictors of sudden death included older age, heart failure, atrial fibrillation, prior MI, higher UACR, and lower systolic BP; effects of finerenone were consistent across CKM subgroups.

Clinical Implications

Consider finerenone to reduce sudden death risk in patients with CKM profiles (T2D+CKD and HFpEF/HFmrEF), alongside standard care. Patients with higher UACR or arrhythmic substrate may particularly benefit; monitor BP and electrolytes per labeling.

Limitations

• Post hoc within-trial endpoint focus; sudden death not the primary endpoint in parent trials
• Potential heterogeneity across trials and relatively low absolute event rates

Future Directions

Define arrhythmic vs non-arrhythmic sudden deaths, assess interaction with device therapy, and test mechanistic biomarkers (e.g., fibrosis, autonomic tone) to refine patient selection.