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卡培立肽低剂量给药治疗急性心力衰竭的效果:LASCAR-AHF试验

Effect of low-dose administration of carperitide for acute heart failure: the LASCAR-AHF trial.

作者信息

Honda Satoshi, Nagai Toshiyuki, Honda Yasuyuki, Nakano Hiroki, Kawabata Takanori, Maeda Hirotada, Asakura Koko, Iwakami Naotsugu, Takenaka Sakae, Kato Yoshiya, Tokuda Yusuke, Yamane Takafumi, Furukawa Yutaka, Kitai Takeshi, Asaumi Yasuhide, Nishihara Shuzo, Mizuno Atsushi, Yamaguchi Tetsuo, Noguchi Teruo, Yasuda Satoshi, Anzai Toshihisa

机构信息

Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565, Japan.

Department of Cardiovascular Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido 060-8638, Japan.

出版信息

Eur Heart J Acute Cardiovasc Care. 2025 Feb 20;14(2):83-92. doi: 10.1093/ehjacc/zuae140.

Abstract

AIMS

The effects of low-dose carperitide on long-term clinical outcomes of patients with acute heart failure (AHF) have not yet been fully elucidated. This study aimed to evaluate the effects of low-dose intravenous carperitide on the long-term clinical outcomes of patients with AHF.

METHODS AND RESULTS

In this multicentre, open-label, randomized controlled trial, 247 patients with AHF received low-dose carperitide intravenously with standard treatment or matching standard treatment for 72 h from November 2014 to March 2021 across nine sites in Japan. The primary endpoint was a composite of all-cause death and heart failure hospitalization within 2 years. The primary endpoint was observed in 36 of 122 patients (29.5%) and 35 of 125 patients (28.0%) in the carperitide group and standard treatment groups, respectively [hazard ratio 1.26; 95% confidence interval (CI) 0.78-2.06, P = 0.827]. No significant differences were observed in the secondary endpoints, including cumulative urine volume at 72 h; change in the degree of dyspnoea over 72 h; and changes in brain natriuretic peptide, cystatin C, renin, aldosterone, and catecholamine levels at 72 h post-randomization between the groups. A greater decrease in the estimated glomerular filtration rate was observed in the carperitide group compared with the standard treatment group (inter-group difference -3.9 mL/min/1.73 m2; 95% CI -7.0 to -0.8).

CONCLUSION

In patients with AHF, low-dose carperitide did not reduce long-term mortality or hospitalization events when combined with standard treatment. Because patient enrolment was terminated prematurely, the study was underpowered and inconclusive.

摘要

目的

小剂量卡培立肽对急性心力衰竭(AHF)患者长期临床结局的影响尚未完全阐明。本研究旨在评估小剂量静脉注射卡培立肽对AHF患者长期临床结局的影响。

方法与结果

在这项多中心、开放标签、随机对照试验中,2014年11月至2021年3月期间,日本9个地点的247例AHF患者接受了小剂量卡培立肽静脉注射联合标准治疗或匹配的标准治疗,持续72小时。主要终点是2年内全因死亡和心力衰竭住院的复合终点。卡培立肽组和标准治疗组分别有122例患者中的36例(29.5%)和125例患者中的35例(28.0%)观察到主要终点事件[风险比1.26;95%置信区间(CI)0.78 - 2.06,P = 0.827]。两组间次要终点无显著差异,包括72小时累计尿量;72小时内呼吸困难程度的变化;随机分组后72小时时脑钠肽、胱抑素C、肾素、醛固酮和儿茶酚胺水平的变化。与标准治疗组相比,卡培立肽组观察到估计肾小球滤过率有更大程度的下降(组间差异 -3.9 mL/min/1.73 m2;95% CI - 7.0至 -0.8)。

结论

在AHF患者中,小剂量卡培立肽与标准治疗联合使用时,并未降低长期死亡率或住院事件。由于患者入组提前终止,该研究效能不足且结论不明确。

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