Compression stockings for treating vasovagal syncope (COMFORTS-II) trial: Rationale and design of a triple-blind, multi-center, randomized controlled trial - 23/05/22

Doi : 10.1016/j.ahj.2022.04.002

Hamed Tavolinejad, MD ^a,^b,^{^{†
These authors contributed equally as co-first authors.}}, Amirhossein Poopak, MD ^a, Saeed Sadeghian, MD ^a, Ali Bozorgi, MD ^a, Alireza Oraii, MD ^c, Reza Mollazadeh, MD ^d, Zahra Emkanjoo, MD ^e, Mohamadreza Kiarsi, MD ^f, Javad Shahabi, MD ^g, Arash Jalali, PhD ^a, Farshid Alaeddini, MD ^a, Hamid Ariannejad, MD ^a, Somayeh Yadangi, MSc ^a, Saeed Oraii, MD ^c, Jalal Kheirkhah, MD ^h, Mohammad Assadianrad, MD ^h, Arya Aminorroaya, MD, MPH ^a,^b, Masih Tajdini, MD ^a,^⁎
^a Tehran Heart Center, Cardiovascular Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran
^b Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
^c Tehran Arrhythmia Center, Tehran, Iran
^d Department of Cardiology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
^e Cardiac Electrophysiology Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran
^f Department of Cardiology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
^g Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran
^h Department of Cardiology, Healthy Heart Research Center, School of Medicine, Guilan University of Medical Sciences, Rasht, Iran

^⁎Reprint requests: Masih Tajdini, MD MPH, Tehran Heart Center, Tehran University of Medical Sciences, Tehran Heart Center, Jalal Al Ahmad, and North Kargar Intersection, Tehran, Iran.Tehran Heart CenterTehran University of Medical SciencesTehran Heart CenterJalal Al Ahmad, and North Kargar IntersectionTehranIran

Résumé

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.

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Keywords : Syncope, Vasovagal, Randomized Controlled Trial, Compression stocking

Plan

Introduction

Material and methods

Ethical considerations and registration

Funding

Randomization, allocation, and blinding

Participants

Interventions

Follow-up and outcomes

Sample size calculation

Informed consent statement

CRediT authorship contribution statement

We hereby declare that none of the authors of this manuscript are representatives of the government and this paper is not submitted on behalf of any government official or institution.

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Vol 249

P. 57-65 - juillet 2022 Retour au numéro

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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 - 23/05/22

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Plan

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