在接受HeartMate 3 LVAD (ENVAD- HF) 患者中评估sacubitril/ valsartan使用的多中心,随机,开放的平行组研究的初步结果
Maja Cikes1, Jasper J Brugts2, Brian Claggett3
1Department of Cardiovascular Diseases, University of Zagreb School of Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.
JACC. Heart failure
|September 2, 2025
概括
在ENVAD- HF试验中发现,在接受HeartMate 3左心室辅助器件 (LVAD) 的人群中,萨库比特里尔/ 瓦尔萨坦是安全且可以容忍的. 这种心力衰竭治疗显示出改善结果的趋势,支持LVAD患者的进一步研究.
科学领域:
- 心脏病学
- 医疗器械
- 药理学
背景情况:
- 在接受左心室辅助器件 (LVAD) 患者心力衰竭治疗的疗效仍在研究中.
- 观察性研究表明神经激素抑制剂可能改善LVAD患者的结果.
- 在 ENVAD- HF 试验中,对接受 HeartMate 3 LVAD 的患者进行了安全性和耐受性评估.
研究的目的:
- 在接受 HeartMate 3 LVAD 的患者中评估萨库比特里尔/ 瓦尔萨坦的安全性和耐受性.
- 在该患者群体中,将sacubitril/ valsartan与标准护理 (SOC) 进行比较.
- 建立未来对LVAD患者心力衰竭特异性治疗的关键试验的基础.
主要方法:
- 进行了一项前性多中心随机开放性研究 (ENVAD- HF).
- 稳定的LVAD接受者被随机分为接受sacubitril/ valsartan或SOC用于血压控制 (MAP目标为75- 90 mmHg).
- 这项研究包括12个月的随访,主要结论和探索性临床,生物标志物和患者报告的结果评估.
主要成果:
- 主要终点 (死亡时间,功能恶化,高血或低血压) 的危险比为0. 42 (p=0. 30),有利于sacubitril/ valsartan,但不具有统计意义.
- 与SOC组相比,sacubitril/ valsartan组发生的主要终点事件较少 (2事件).
- 萨库比特里尔/ 瓦尔萨坦的使用与血压药物显著降低 (p < 0. 0001) 和改善堪萨斯城心肌病问卷总结得分 (p=0. 011).
结论:
- 在ENVAD- HF试验中,萨库比特里尔/ 瓦尔萨坦在稳定的HeartMate 3 LVAD患者中是安全的,耐受性良好.
- 这项研究提供了支持对LVAD群体抗胰岛素抑制的证据.
- 这些发现为一项关键试验铺平了道路,以证实对LVAD患者的HF特异性治疗的临床效用.
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