Abstract：
OBJECTIVE: One third of patients do not improve after cardiac resynchronization therapy (CRT). Septal flash (SF) and apical rocking (ApRock) are deformation patterns observed on echocardiography in most patients eligible for CRT. These markers of mechanical dyssynchrony have been associated to improved outcome after CRT in observational studies and may be useful to better select patients. The aim of this trial is to investigate whether the current guideline criteria for selecting patients for CRT should be modified and include SF and ApRock to improve therapy success rate, reduce excessive costs and prevent exposure to device-related complications in patients who would not benefit from CRT.
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.
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.
摘要：
目的：三分之一的患者在心脏再同步化治疗（CRT）后没有改善。中隔闪光（SF）和根尖摇摆（ApRock）是大多数符合CRT条件的患者在超声心动图上观察到的变形模式。在观察性研究中，这些机械不同步的标志物与CRT后改善的结果相关，可能有助于更好地选择患者。本试验的目的是研究是否应修改当前选择CRT患者的指南标准，并包括SF和ApRock以提高治疗成功率，在无法从CRT获益的患者中,降低过高的费用并防止暴露于与设备相关的并发症.
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.
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.
