Qiu Ruowu, Ni Qingqing, Wu Muli, Xiao Zhongbo, Xiao Jiaxin, Lin Weizhao, Huang Weipeng, Chen Yequn, Chen Chang, Hong Liekai
Cardiology Department, The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, China.
Shantou University Medical College, Shantou, Guangdong, China.
Front Cardiovasc Med. 2024 Jan 29;11:1303540. doi: 10.3389/fcvm.2024.1303540. eCollection 2024.
A high recurrence rate of atrial fibrillation was monitored after catheter ablation for persistent atrial fibrillation. Sacubitril/valsartan can improve outcomes for patients with heart failure and ventricular tachycardia, but few studies examined whether it can reduce recurrence or improve cardiovascular outcomes in patients with persistent atrial fibrillation after catheter ablation. In this study, we will assess the effect of sacubitril/valsartan on sinus rhythm maintenance and incidence of major adverse cardiovascular events (MACE) in patients with persistent atrial fibrillation after catheter ablation through a randomized controlled trial (RCT).
This is a multi-center, randomized, controlled, open-label, superiority clinical trial involving 462 patients without reduced ejection fraction heart failure after catheter ablation of persistent atrial fibrillation. Patients will be randomized to (1) receive the standard treatment strategy plus sacubitril/valsartan titration, or (2) receive the standard treatment strategy without taking sacubitril/valsartan. The primary outcome will be sinus rhythm maintenance rate over 12 months, monitored by random electrocardiogram and 24-h Holter electrocardiogram.
This study is designed to evaluate the effect of sacubitril/valsartan on sinus rhythm maintenance and incidence of major adverse cardiovascular events (MACE) in patients with persistent atrial fibrillation after catheter ablation. The results will evaluate sacubitril/valsartan as a novel treatment for improving prognosis and a complement to conventional drug therapy.
Registered with Chinese Clinical Trials Registry on 27 August 2022, identifier: ChiCTR2200062995.
持续性心房颤动导管消融术后房颤复发率较高。沙库巴曲缬沙坦可改善心力衰竭和室性心动过速患者的预后，但很少有研究探讨其能否降低持续性心房颤动导管消融术后患者的复发率或改善心血管结局。在本研究中，我们将通过一项随机对照试验（RCT）评估沙库巴曲缬沙坦对持续性心房颤动导管消融术后患者窦性心律维持及主要不良心血管事件（MACE）发生率的影响。
这是一项多中心、随机、对照、开放标签的优效性临床试验，纳入462例持续性心房颤动导管消融术后射血分数未降低的心力衰竭患者。患者将被随机分为两组：（1）接受标准治疗策略加沙库巴曲缬沙坦滴定治疗，或（2）接受不服用沙库巴曲缬沙坦的标准治疗策略。主要结局为12个月时的窦性心律维持率，通过随机心电图和24小时动态心电图监测。
本研究旨在评估沙库巴曲缬沙坦对持续性心房颤动导管消融术后患者窦性心律维持及主要不良心血管事件（MACE）发生率的影响。研究结果将评估沙库巴曲缬沙坦作为一种改善预后的新型治疗方法以及对传统药物治疗的补充。
于2022年8月27日在中国临床试验注册中心注册，标识符：ChiCTR2200062995。
