在心力衰竭中,传导系统节奏和心房结节切除:PACE-FIB研究设计
Daniel Rodríguez Muñoz1,2, María Generosa Crespo-Leiro3,4,5, Ignacio Fernández Lozano6,7
1Cardiology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
ESC heart failure
|September 21, 2023
概括
左束枝节奏 (LBBP) 结合心房结节切除 (AVNA) 显示出心力衰竭患者与心房动 (AF) 的承诺. 这项研究将LBBP-AVNA与药物治疗进行比较,以改善心力衰竭的治疗结果,并保持或轻微减少射出分数.
科学领域:
- 心脏病学 心脏病学
- 电子生理学 电子生理学
- 心脏衰竭研究研究
背景情况:
- 心房动 (AF) 对心力衰竭 (HF) 患者的预后产生负面影响.
- 对于心力衰竭中的永久性AF,有效的治疗方法有限,具有保存的喷射分数 (HFpEF) 或轻微减少的喷射分数 (HFmrEF).
研究的目的:
- 评估心率调节的长期益处和安全性,使用左束枝节奏 (LBBP) 和心房结节切除 (AVNA).
- 将LBBP-AVNA策略与HFpEF/HFmrEF永久性AF患者的标准药理速率控制进行比较.
主要方法:
- 该PACE-FIB试验是一个前性,多中心,开放标签,随机化研究 (1:1比).
- 334名患有HFpEF/HFmrEF和永久性AF的患者将随机分配到LBBP,其次是AVNA或最佳药理速率控制.
- 随访持续时间至少为36个月,主要结局包括全因死亡率,HF住院和HF恶化.
主要成果:
- 该研究正在进行中,招聘时间为2022年3月至2027年2月.
- 36个月后的初级结果数据将评估复合终点.
- 二级结局包括心声回声学参数,功能状态和不良事件.
结论:
- 左束枝节奏 (LBBP) 是心率调节的一个有前途的方法.
- 在这种患者群体中,节奏和减缓策略 (LBBP + AVNA) 可能会比药理控制率提供临床益处.
- 这是第一个随机试验,用于研究LBBP-AVNA在永久性AF的HFpEF/HFmrEF中长期有效性和安全性.
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