Biomarker, Functional Status, and Quality-of-Life Trajectories Before Modes of Death in Heart Failure: Post Hoc Analysis of the FINEARTS-HF Randomized Clinical Trial.

Background

To characterize clinical trajectories preceding sudden death in patients with HFmrEF or HFpEF and compare them with trajectories before other modes of death and survival. DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc analysis of the Finerenone Trial to Investigate the Efficacy and Safety Superior to Placebo in Patients With Heart Failure (FINEARTS-HF) randomized clinical trial evaluating trajectories of functional status, patient-reported health status, and natriuretic peptide levels preceding adjudicated modes of death.

本研究旨在描述HFmrEF或HFpEF患者猝死前的临床轨迹，并将其与死亡的其他方式及存活前的轨迹进行比较。

This was a global, event-driven clinical trial. Patients with symptomatic HF, left ventricular EF of 40% or greater, New York Heart Association class (NYHA) II to IV, and elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) were enrolled between September 14, 2020, and January 10, 2023.

这是一项全球性的、以事件驱动的临床试验。招募了有症状的心力衰竭患者，左心室射血分数为40%或以上，纽约心脏协会（NYHA）II至IV级，以及N末端前体B型利钠肽（NT-proBNP）水平升高，入组时间为2020年9月14日至2023年1月10日。

Data analysis was conducted in December 2025.

数据分析于2025年12月进行。

Methods

Finerenone vs placebo.

Finerenone 与安慰剂的比较。

main_outcomes_and_measures

Longitudinal trajectories of NYHA class, Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS), and NT-proBNP levels preceding sudden death were compared with trajectories in survivors and those who died of HF-related, nonsudden cardiovascular, or noncardiovascular causes, using linear mixed-effects models with restricted cubic splines.

使用带有限制性立方样条的线性混合效应模型，比较了纽约心脏病协会（NYHA）功能分级、堪萨斯城心肌病问卷总症状评分（KCCQ-TSS）以及NT-proBNP水平在突发死亡前的纵向轨迹，与存活者以及因心力衰竭相关、非突发心血管或非心血管原因死亡者的轨迹进行比较。

Results

Included in this analysis were 6001 patients (mean [SD] age, 72.0 [9.6] years; 3269 male [54%]).

本分析纳入了6001名患者（平均年龄[标准差]为72.0[9.6]岁；3269名为男性[占54%]）。

Over a median (IQR) follow-up of 2.7 (1.9-3.0) years, 215 sudden deaths occurred.

在中位数（四分位数间距）为2.7（1.9-3.0）年的随访期间，发生了215例突发死亡。

In the 6 months before death, sudden death was preceded by a slight worsening in physician-assigned NYHA class (from approximately 2.3 to 2.4), worsening self-reported health status (an approximately 8-point decline in KCCQ-TSS), and a gradual rise in NT-proBNP levels (from approximately 1800 to 2000 pg/mL).

在死亡前的6个月里，突发死亡前医生评定的纽约心脏病协会（NYHA）心功能分级略有恶化（从大约2.3增加到2.4），自我报告的健康状况恶化（KCCQ-TSS评分下降约8分），NT-proBNP水平逐渐上升（从大约1800 pg/mL增加到2000 pg/mL）。

In contrast, among patients who survived, NYHA class improved (from approximately 2.3 to 2.1), KCCQ-TSS increased (from approximately 68 to 77), and NT-proBNP levels declined (from approximately 800 to 650 pg/mL) over the 18 months before the end of follow-up.

相比之下，在存活的患者中，NYHA心功能分级在随访结束前的18个月有所改善（从大约2.3改善到2.1），KCCQ-TSS评分增加（从大约68增加到77），NT-proBNP水平下降（从大约800 pg/mL下降到650 pg/mL）。

Comparable patterns of deterioration to those preceding sudden death, often more pronounced, were observed before other modes of death.

在其他死亡方式之前，观察到与突然死亡前相似的恶化模式，通常更为明显。

conclusions_and_relevance

Results of this post hoc analysis of the FINEARTS-HF randomized clinical trial reveal that in this contemporary HFmrEF or HFpEF cohort, sudden death was preceded by modest worsening of symptoms, declining quality of life, and rising natriuretic peptide levels, suggesting many of these events may not have been entirely sudden.

对FINEARTS-HF随机临床试验的事后分析结果显示，在这个现代的HFmrEF或HFpEF队列中，突然死亡之前出现了症状的适度恶化、生活质量的下降和利钠肽水平的上升，这表明这些事件中的许多可能并非完全突然。

However, similar deterioration preceding other modes of death suggests limited specificity for sudden death.

然而，类似的恶化出现在其他死亡方式之前表明对猝死的特异性有限。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

ClinicalTrials.gov 注册号：NCT04435626。