口服利尿强化作为恶化的心力衰竭事件在临床试验的主要结果
Harriette G C Van Spall1,2, Joan Carles Trullàs3,4, Darren K McGuire5,6
1Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
NEJM evidence
|December 8, 2025
概括
本研究建议在临床试验中扩大心力衰竭 (HF) 恶化的定义,包括口服利尿强化 (ODI). 这一变化旨在更好地捕捉HF事件,并提高心力衰竭治疗的试验准确性.
科学领域:
- 心脏病学 心脏病学
- 临床试验方法论 临床试验方法论
- 药物治疗研究 药物治疗研究
背景情况:
- 基于证据的疗法可以降低心力衰竭 (HF) 的死亡率,但仍然存在诸如恶化HF等结果的残留风险.
- 目前的HF试验经常使用复合结果,包括住院治疗或IV药物治疗,以使HF恶化.
- 现有的定义可能低估了HF事件恶化的真正负担.
研究的目的:
- 建议在临床试验中扩大HF恶化的定义.
- 包括使用门诊口服利尿强化 (ODI) 治疗的HF发作.
- 分析包括ODI在事件率和治疗效果估计上的影响.
主要方法:
- 从慢性HF药物治疗试验中对后期分析的审查.
- 检查ODI的预后意义.
- 模拟将外投资融入复合终点中的影响.
主要成果:
- 后期分析表明,ODI在慢性HF中具有预后意义.
- 将ODI纳入试验定义可能会改变预期事件率.
- 估计的治疗效应可能会受到HF恶化的更广泛定义的影响.
结论:
- 建议在临床试验中扩大恶化HF的定义,以包括ODI.
- 建议对ODI进行标准化定义.
- 将ODI纳入HF试验终点的挑战和监管方面需要讨论.
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