METHODS: The AMEND-CRT trial is a multicentre, randomized, parallel-group, double-blind, sham-controlled trial with a non-inferiority design. The trial will include 578 patients scheduled for CRT according to the 2021 ESC guidelines who satisfy all inclusion criteria. The randomization is performed 1:1 to an active control arm (\'guideline arm\') or an experimental arm (\'echo arm\'). All participants receive a device, but in the echo arm, CRT is activated only when SF or ApRock or both are present. The outcome of both arms will be compared after 1 year. The primary outcome measures are the average change in left ventricular end-systolic volume and patient outcome assessed using a modified Packer Clinical Composite Score.
CONCLUSIONS: The findings of this trial will redefine the role of echocardiography in CRT and potentially determine which patients with heart failure and a prolonged QRS duration should receive CRT, especially in patients who currently have a class IIa or class IIb recommendation.
方法:AMEND-CRT试验是一个多中心,随机化,平行组,双盲,具有非劣效性设计的假对照试验。该试验将包括根据2021年ESC指南计划接受CRT的578名患者,他们满足所有纳入标准。以1:1对主动控制臂(“指导臂”)或实验臂(“回声臂”)进行随机化。所有参与者都收到一个设备,但是在回声臂中,仅当SF或ApRock或两者都存在时,才会激活CRT。两组的结果将在1年后进行比较。主要结果指标是左心室收缩末期容积的平均变化和使用改良的Packer临床综合评分评估的患者结果。
结论:这项试验的结果将重新定义超声心动图在CRT中的作用,并有可能确定哪些心力衰竭和QRS持续时间延长的患者应该接受CRT,尤其是在目前有IIa类或IIb类推荐的患者中.