Maimaitijiang Pakezhati, Tu Bin, Lai Zihao, Chen Aiyue, Zhang Zhuxin, Zhou Likun, Cai Simin, Zheng Lihui, Yao Yan
Fuwai Hospital, National Center for Cardiovascular Diseases, National Key Laboratory, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100037, China.
Cardiac Center, Beijing Chaoyang Hospital, Capital Medical University, Beijing, 100020, China.
J Interv Card Electrophysiol. 2025 Mar;68(2):257-265. doi: 10.1007/s10840-025-02029-4. Epub 2025 Mar 21.
Current treatment strategies for vasovagal syncope (VVS) patients recommended by the guidelines are diverse, but effects of these therapies are still unsatisfactory with respective limitations on the indications. Cardioneuroablation (CNA), an innovative and promising therapy, has shown potently effective against syncopal recurrences in numerous observational studies. Recently, a single-center randomized clinical trial has reported CNA was superior to non-pharmacologic therapy for VVS patients. Therefore, this study is designed to compare the efficacy of CNA with pharmacologic treatment in a multicenter and randomized fashion.
The Cardioneuroablation versus Midodrine in Patients with Vasovagal Syncope (CAMPAIGN) study is an international multicenter, prospective, open-label, randomized controlled trial. The recurrent VVS patients with a positive response to tilt testing despite sufficient conventional treatment will be predominantly enrolled at different medical centers in China, Russia, and Turkey. All eligible participants will be randomized in a ratio of 1:1 to treatment with CNA versus midodrine, and followed up for 12 months after randomization. Approximately 184 subjects are projected to enroll from April 2023 to December 2024 with follow-up until 2025. The primary endpoint is the recurrence rate of syncope at 12 months of follow-up. The secondary endpoints are comprised of quality of life assessed with the Impact of Syncope on Quality of Life, tilt-induced syncope, blood pressure, cardiac deceleration capacity, and heart rate variability.
A prospective and multicenter clinical trial to compare outcomes of CNA with drug therapy is still lacking. The CAMPAIGN study will provide outcome-based evidence for VVS treatment strategy.
Clinicaltrials.gov: NCT05803148 (Date: March 9, 2023).
指南推荐的目前用于血管迷走性晕厥（VVS）患者的治疗策略多种多样，但这些疗法的效果仍不尽人意，且各自在适应证方面存在局限性。心脏神经消融术（CNA）是一种创新且有前景的疗法，在众多观察性研究中已显示出对晕厥复发有显著疗效。最近，一项单中心随机临床试验报告称，CNA对VVS患者优于非药物治疗。因此，本研究旨在以多中心随机方式比较CNA与药物治疗的疗效。
血管迷走性晕厥患者心脏神经消融术与米多君对比研究（CAMPAIGN）是一项国际多中心、前瞻性、开放标签、随机对照试验。尽管接受了充分的常规治疗，但对倾斜试验有阳性反应的复发性VVS患者将主要在中国、俄罗斯和土耳其的不同医疗中心入组。所有符合条件的参与者将按1:1的比例随机分为接受CNA治疗组和米多君治疗组，并在随机分组后随访12个月。预计从2023年4月至2024年12月将有大约184名受试者入组，随访至2025年。主要终点是随访12个月时的晕厥复发率。次要终点包括用晕厥对生活质量的影响评估的生活质量、倾斜诱发的晕厥、血压、心脏减速能力和心率变异性。
目前仍缺乏一项前瞻性多中心临床试验来比较CNA与药物治疗的结果。CAMPAIGN研究将为VVS治疗策略提供基于结果的证据。
Clinicaltrials.gov：NCT05803148（日期：2023年3月9日）。
