Effect of Cardioneuroablation vs Midodrine on Syncope Recurrence Among Patients With Vasovagal Syncope: The CAMPAIGN Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective, international multi-center, open-labeled, randomized trial. The investigator speculated that CNA prevents more patients with moderate to severe VVS from syncope recurrence compared to midodrine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years of age

• Calgary Syncope Symptom Score ≥ -2 points

• Positive response to head-up tilt test

• With syncope episodes more than 3 times in the preceding year

• A proven failure of non-pharmacologic treatment, including reassurance regarding the benign prognosis, education about the avoidance of situations and triggers initiating syncope, application of PCM during the occurrence of prodromal symptoms, and lifestyle modifications(adequate fluid intake and salt supplementation), according to the guideline

• Willingness to comply with follow-up requirements and to sign the informed consent

Locations
Other Locations
China
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Beijing
Contact Information
Primary
yan Yao, PhD
ianyao@263.net.cn
13901121319
Backup
lihui Zheng, PhD
zhenglihui@263.net
13910617612
Time Frame
Start Date: 2023-04-05
Estimated Completion Date: 2024-12-30
Participants
Target number of participants: 184
Treatments
Experimental: Experimental group: Cardioneuroablation
In this arm, the catheter ablation of the GPs will be performed in the order of LSGP, LIGP, RIGP, left atrial RAGP and right atrial RAGP. Patient education includes fully informing patients of the benign prognosis of vasovagal syncope, and educating patients to avoid triggering factors as much as possible. At the same time, the patient should be taught how to cope with the impending syncope with physical counter-pressure maneuvers and dietary suggestions that emphasize fluid and sodium intake.
Active_comparator: Control group: Midodrine
In this arm, Midodrine will be applied without the following contraindications: hypertension, chromaffin cell carcinoma, acute nephritis, severe renal dysfunction, glaucoma, prostatic hyperplasia with urinary retention, mechanical urinary obstruction, hyperthyroidism. Patient education includes fully informing patients of the benign prognosis of vasovagal syncope, and educating patients to avoid triggering factors as much as possible. At the same time, the patient should be taught how to cope with the impending syncope with physical counter-pressure maneuvers and dietary suggestions that emphasize fluid and sodium intake.
Sponsors
Collaborators: Fuwai Yunnan Cardiovascular Hospital, Henan Provincial People's Hospital, RenJi Hospital, First Affiliated Hospital Xi'an Jiaotong University, Yeditepe University Hospital, Beijing Chao Yang Hospital, Ningbo No. 1 Hospital, First Affiliated Hospital, Sun Yat-Sen University
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov