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Compression Stockings for Treating Vasovagal Syncope (Comforts-Ii) Trial: Rationale and Design of a Triple-Blind, Multi-Center, Randomized Controlled Trial Publisher Pubmed



Tavolinejad H1, 2 ; Poopak A1 ; Sadeghian S1 ; Bozorgi A1 ; Oraii A3 ; Mollazadeh R4 ; Emkanjoo Z5 ; Kiarsi M6 ; Shahabi J7 ; Jalali A1 ; Alaeddini F1 ; Ariannejad H1 ; Yadangi S1 ; Oraii S3 Show All Authors
Authors
  1. Tavolinejad H1, 2
  2. Poopak A1
  3. Sadeghian S1
  4. Bozorgi A1
  5. Oraii A3
  6. Mollazadeh R4
  7. Emkanjoo Z5
  8. Kiarsi M6
  9. Shahabi J7
  10. Jalali A1
  11. Alaeddini F1
  12. Ariannejad H1
  13. Yadangi S1
  14. Oraii S3
  15. Kheirkhah J8
  16. Assadianrad M8
  17. Aminorroaya A1, 2
  18. Tajdini M1
Show Affiliations
Authors Affiliations
  1. 1. Tehran Heart Center, Cardiovascular Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Tehran Arrhythmia Center, Tehran, Iran
  4. 4. Department of Cardiology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Cardiac Electrophysiology Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran
  6. 6. Department of Cardiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
  7. 7. Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
  8. 8. Department of Cardiology, Healthy Heart Research Center, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran

Source: American Heart Journal Published:2022


Abstract

Background: Reduced venous return is an important trigger of vasovagal syncope (VVS). Elastic compression stockings (ECS) can modify venous return and be of therapeutic interest; however, evidence for ECS efficacy in VVS is scarce. This randomized controlled trial was designed to address the issue. Methods: COMFORTS-II is a multicenter, triple-blind, parallel design, randomized controlled trial aimed to assess the efficacy of ECS in preventing VVS recurrences. Using central online randomization, 268 participants will be allocated to 2 arms (1:1 ratio), wearing intervention ECS (25-30 mm Hg pressure) or sham ECS (≤10 mm Hg pressure). All participants will receive standard VVS treatment in the form of education, and lifestyle modification recommendations (drinking 2-3 l/d of fluids and consuming 10 g/d—roughly half a tablespoon—of table salt). Adherence to ECS treatment will be evaluated through diary sheets, and compared between study arms. Follow-up continues for 1 year, and is conducted via a 24/7 phone line available to patients and trimonthly visits. The co-primary outcomes are proportion of participants with any syncopal recurrence and time to first syncopal episode. Secondary outcomes include frequency of VVS spells, time intervals between recurrences, and incidence of any patient-reported adverse effects. Conclusion: To the best of our knowledge, COMFORTS-II is the first clinical trial to assess ECS efficacy among patients with VVS, addressing an important gap in evidence for VVS treatments. © 2022
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