What is the clinical evidence from this study?

Study design: Meta-Analysis. Population: Cardio-kidney-metabolic (CKM) syndrome. Intervention: Finerenone vs. Placebo. Primary outcome: Sudden death.

What does this research mean for the field?

Finerenone is associated with a lower risk of sudden death in patients across the cardio-kidney-metabolic spectrum. Novelty: ClaimNovelty.SYNTHESIS. Consensus alignment: ConsensusAlignment.NEUTRAL.

June 5, 2026Open Access

Effects of Finerenone on Sudden Death Across the Cardio-Kidney-Metabolic Landscape

Key Result

Finerenone was associated with a lower risk of sudden death across the cardio-kidney-metabolic spectrum.

Key Points

This research investigates the impact of finerenone on sudden death in patients with cardio-kidney-metabolic syndrome and identifies independent predictors of sudden death.
Pooled participant-level data from 3 placebo-controlled trials of finerenone in CKM syndrome
Multivariable Cox regression models used to identify predictors of sudden death
Cox models stratified by region and trial to examine treatment effects on sudden death.
Finerenone was associated with a lower risk of sudden death across the cardio-kidney-metabolic spectrum.
Specific event rates and statistical significance were verified, with a noted confidence interval (CI).
Clinical predictors of sudden death were identified in the analysis.

Study Design

Type

Meta-Analysis

Multicenter

Yes

Structured PICO

Does finerenone reduce sudden death in patients with cardio-kidney-metabolic syndrome?

Population

Pooled analysis of patients with cardio-kidney-metabolic syndrome from 3 placebo-controlled trials.

Intervention

Finerenone (nonsteroidal mineralocorticoid receptor antagonist)

Comparator

Placebo

Outcome

Sudden death (centrally adjudicated by a blinded clinical endpoint committee)hard clinical

In a pooled analysis of 3 trials, finerenone was associated with a reduced risk of sudden death among patients with cardio-kidney-metabolic syndrome.

Abstract

BACKGROUND: The nonsteroidal mineralocorticoid receptor antagonist finerenone has been shown to improve cardiovascular and kidney outcomes in patients with cardio-kidney-metabolic (CKM) syndrome, but its effects on sudden death (SD) are uncertain. OBJECTIVES: We investigated independent predictors of SD and treatment effects of finerenone on SD. METHODS: In this prespecified FINE-HEART analysis, we pooled participant-level data from 3 placebo-controlled trials of finerenone in CKM syndrome, including 2 trials of chronic kidney disease with type 2 diabetes (FIDELIO-DKD Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease and FIGARO-DKD Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease) and a trial of heart failure with mildly reduced ejection fraction/heart failure with preserved ejection fraction (FINEARTS-HF FINerenone trial to investigate Efficacy and sAfety superioR to placebo in paTientS with Heart Failure). SD in each trial was centrally adjudicated by a blinded clinical endpoint committee. We identified clinical predictors of SD in multivariable Cox regression models and examined treatment effects of finerenone on SD in Cox models stratified by region and trial. RESULTS: = 0.71). CONCLUSIONS: The nonsteroidal mineralocorticoid receptor antagonist finerenone was associated with a lower risk of SD across the CKM spectrum. (FINE-HEART: An Integrated Pooled Analysis of Finerenone across 3 Phase III Trials of Heart Failure and Chronic Kidney Disease and Type 2 Diabetes; CRD42024570467).

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