drugset / Trial / NCT05803148
Treatment Strategy of Vasovagal Syncope
Unknown
184 enrolled
China National Center for Cardiovascular Diseases
Beijing Chao Yang Hospital · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabFuwai Yunnan Cardiovascular Hospital · collabHenan Provincial People's Hospital · collabNingbo No. 1 Hospital · collabRenJi Hospital · collabYeditepe University Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2023-04-05
- Primary completion
- 2024-12-30
- Completion
- 2024-12-30
Publications
- Results Tu B, Wu L, Hu F, Fan S, Liu S, Liu L, Ding L, Zheng L, Yao Y. Cardiac deceleration capacity as an indicator for cardioneuroablation in patients with refractory vasovagal syncope. Heart Rhythm. 2022 Apr;19(4):562-569. doi: 10.1016/j.hrthm.2021.12.007. Epub 2021 Dec 9.
- Results Sheldon R, Faris P, Tang A, Ayala-Paredes F, Guzman J, Marquez M, Morillo CA, Krahn AD, Kus T, Ritchie D, Safdar S, Maxey C, Raj SR; POST 4 investigators. Midodrine for the Prevention of Vasovagal Syncope : A Randomized Clinical Trial. Ann Intern Med. 2021 Oct;174(10):1349-1356. doi: 10.7326/M20-5415. Epub 2021 Aug 3.
- Results Hu F, Zheng L, Liang E, Ding L, Wu L, Chen G, Fan X, Yao Y. Right anterior ganglionated plexus: The primary target of cardioneuroablation? Heart Rhythm. 2019 Oct;16(10):1545-1551. doi: 10.1016/j.hrthm.2019.07.018. Epub 2019 Jul 19.
- Maimaitijiang P, Tu B, Lai Z, Chen A, Zhang Z, Zhou L, Cai S, Zheng L, Yao Y; CAMPAIGN Investigators. The Efficacy of Cardioneuroablation versus Midodrine in Patients with Vasovagal Syncope: Design and Rationale for the CAMPAIGN Trial. J Interv Card Electrophysiol. 2025 Mar;68(2):257-265. doi: 10.1007/s10840-025-02029-4. Epub 2025 Mar 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Midodrine | Small molecule | 2.5 mg | Oral |
| Comparator | Midodrine | Small molecule | 5 mg | Oral |
| Comparator | Midodrine | Small molecule | 10 mg | Oral |