Finerenone in Heart Failure With Improved Ejection Fraction: The FINEARTS-HF Randomized Clinical Trial.

Background

To assess the clinical profiles, risk, and treatment response to finerenone in participants with HFimpEF.

评估HFimpEF参与者的临床特征、风险以及对非奈利酮的治疗反应。

DESIGN, SETTING, AND PARTICIPANTS: A total of 6001 patients with HE, LVEF of 40% or higher, New York Heart Association class II to IV symptoms, and elevated natriuretic peptide levels, were enrolled between September 14, 2020, and January 10, 2023.

设计、设置和参与者：在2020年9月14日至2023年1月10日期间，共有6001名患者被纳入研究，这些患者患有心力衰竭（HE），左心室射血分数（LVEF）为40%或更高，纽约心脏协会（New York Heart Association）II至IV级症状，并且有升高的利钠肽水平。

Patients with a prior history of LVEF less than 40% were included.

包括了既往左心室射血分数（LVEF）小于40%的患者。

Data analysis was conducted between September 1 to December 10, 2024.

数据分析是在2024年9月1日至12月10日期间进行的。

intervention

Participants received finerenone (titrated to 20 mg or 40 mg) or placebo.

参与者接受了非奈利酮（调整剂量至20毫克或40毫克）或安慰剂。

main_outcomes_and_measures

The primary end point was the composite of cardiovascular (CV) death and total (first and recurrent) worsening HF events.

主要终点是心血管（CV）死亡和总（首次和复发）恶化的心力衰竭（HF）事件的复合终点。

Results

Of the 6001 participants (mean [SD] age, 72 [9.7], years; 3269 male [55%]), 273 (5%) had a prior LVEF less than 40%.

在6001名参与者（平均[标准差]年龄为72[9.7]岁；3269名男性[55%]）中，有273人（5%）既往左心室射血分数（LVEF）小于40%。

Among those with a prior LVEF of less than 40%, the median recorded prior LVEF was 35% [IQR, 30%-37%], with a median improvement of 12% [IQR, 8%-17%].

在既往左心室射血分数（LVEF）低于40%的患者中，记录的中位数LVEF为35% [四分位数间距（IQR），30%-37%]，中位数改善为12% [IQR, 8%-17%]。

Over a median follow-up of 2.6 years, those with a history of LVEF of less than 40% experienced higher rates of the primary outcome of a composite of CV death and worsening of HF events (21.4 per 100 patient-years vs 16.0 per 100 patient-years) than did those whose LVEF was consistently 40% or higher.

在中位随访2.6年的时间里，既往LVEF低于40%的患者发生心血管死亡和心力衰竭恶化事件复合终点的比率（每100患者年21.4次）高于那些LVEF始终为40%或更高的患者（每100患者年16.0次）。

After adjustment for clinically relevant covariates; however, this rate ratio (RR) was not statistically different (absolute RR, 1.13; 95% CI, 0.85-1.49, P = .39).

在调整了临床相关协变量后，这个率比（RR）在统计学上并没有显著差异（绝对RR，1.13；95% 置信区间，0.85-1.49，P = .39）。

The treatment effect of finerenone on the primary outcome was consistent among those with a history of LVEF less than 40% and those with LVEF that was consistently 40% or higher (P for interaction = .36).

在那些有LVEF小于40%病史的患者中，以及那些LVEF始终为40%或更高的患者中，finerenone对主要结果的治疗效果是一致的（交互作用P值 = .36）。

Owing to higher baseline risk, the absolute risk reduction was greater among those with HFimpEF (9.2 vs 2.5 per 100 patient-years).

由于基线风险较高，心力衰竭合并射血分数受损（HFimpEF）患者的绝对风险降低更大（每100患者年9.2比2.5）。

Patients with HFimpEF tended to develop more hypotension with finerenone treatment, but otherwise, the safety profile of finerenone was similar in patients with and without previous LVEF less than 40%.

心力衰竭合并射血分数受损（HFimpEF）的患者在接受芬那酮治疗时更易出现低血压，但在有无既往左心室射血分数（LVEF）小于40%的患者中，芬那酮的安全性概况相似。

conclusions_and_relevance

In this prespecified analysis of a randomized clinical trial, patients with HFimpEF remained at high risk of CV events, underscoring the need for continued management despite LVEF improvement.

在这项预先设定的随机临床试验分析中，射血分数保留型心力衰竭（HFimpEF）患者的心血管事件风险依然很高，这强调了即使左心室射血分数（LVEF）有所改善，仍需持续管理的必要性。

The treatment benefits of finerenone observed among the overall population of patients with HF with preserved EF were consistent among patients with HFimpEF.

在射血分数保留型心力衰竭患者的整体人群中观察到的finerenone治疗益处，在射血分数改善型心力衰竭（HFimpEF）患者中也是一致的。

trial_registration

ClinicalTrials.gov Identifier: NCT04435626.

临床试验注册号：NCT04435626。