症状负担作为临床结果评估心力衰竭患者心房的患者
Ian A Carroll1, Jonathan P Piccini2, Benjamin A Steinberg3
1Division of Cardiology, University of Colorado School Anschutz Medical Campus, Aurora, Colorado, USA; Cardiovascular Institute, University of Colorado School Anschutz Medical Campus, Aurora, Colorado, USA; ARCA Biopharma, Westminster, Colorado, USA.
JACC. Heart failure
|November 21, 2024
概括
在心房 (AF) 和心力衰竭 (HF) 患者中测量症状负担的新方法比传统的终点更有效. 这种方法有助于检测治疗差异,并优化AF预防临床试验设计.
科学领域:
- 心血管医学 心血管医学
- 临床试验方法论 临床试验方法论
- 患者报告的结果
背景情况:
- 在心力衰竭 (HF) 中治疗心房动 (AF) 的药理疗仍然是一个未满足的临床需求.
- 目前的AF临床试验终点,如时间到第一个症状性AF事件 (TTFSE),有局限性.
- 随着时间的推移,衡量AF症状负担可以提供更强大的结果评估.
研究的目的:
- 开发和验证一种新的方法来量化AF症状负担,特别是在患有HF的患者中.
- 与临床试验中的传统终点相比,评估这种新方法的效率.
主要方法:
- 开发了心房动症状问卷 (AFSQ),这是一个患者报告的AF/HF人群的结果工具.
- 整合了AFSQ症状数据与心电图记录的AF,以创建一个复合结果测量 (SxBAF).
- 在267名患者的AF/HF试验中,通过心理测试,定验证和与TTFSE进行比较,验证了SxBAF.
主要成果:
- SxBAF在检测治疗差异方面表现出卓越的效率,可能减少临床试验样本大小.
- SxBAF与设备检测到的AF负担 (斯皮尔曼的 ρ = 0.74) 显示出强烈的相关性,并允许症状严重程度的分级.
- SxBAF在心血管不良事件和AF干预方面发现了治疗组的显著差异.
结论:
- 在随访期间测量症状负担对于AF/HF患者群体来说是可行的和有价值的.
- 在AF预防试验中,SxBAF结果评估是评估以患者为中心的结果的有希望的工具.
- 这种方法可以提高未来对高频AF的临床试验的设计和效率.
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