Publication:
Comparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trial

Issued Date

2021-07-01

Resource Type

Article

ISSN

10976744
00028703

DOI

10.1016/j.ahj.2021.03.002

Other identifier(s)

2-s2.0-85103736099

Rights

Mahidol University

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SCOPUS

Bibliographic Citation

American Heart Journal. Vol.237, (2021), 5-12

Suggested Citation

Arya Aminorroaya, Hamed Tavolinejad, Saeed Sadeghian, Arash Jalali, Farshid Alaeddini, Zahra Emkanjoo, Reza Mollazadeh, Ali Bozorgi, Saeed Oraii, Mohamadreza Kiarsi, Javad Shahabi, Mohammad Ali Akbarzadeh, Behzad Rahimi, Adel Joharimoghadam, Abolfazl Mohsenizade, Roghayeh Mohammadi, Alireza Oraii, Hamid Ariannejad, Sanatcha Apakuppakul, Tachapong Ngarmukos, Masih Tajdini Comparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trial. American Heart Journal. Vol.237, (2021), 5-12. doi:10.1016/j.ahj.2021.03.002 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/78101

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Title

Comparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trial

Author(s)

Arya Aminorroaya
 Hamed Tavolinejad
 Saeed Sadeghian
 Arash Jalali
 Farshid Alaeddini
 Zahra Emkanjoo
 Reza Mollazadeh
 Ali Bozorgi
 Saeed Oraii
 Mohamadreza Kiarsi
 Javad Shahabi
 Mohammad Ali Akbarzadeh
 Behzad Rahimi
 Adel Joharimoghadam
 Abolfazl Mohsenizade
 Roghayeh Mohammadi
 Alireza Oraii
 Hamid Ariannejad
 Sanatcha Apakuppakul
 Tachapong Ngarmukos
 Masih Tajdini

Other Contributor(s)

Rajaie Cardiac Electrophysiology Research Center
 Ramathibodi Hospital
 Cardiac Rehabilitation Research Center, Isfahan UMS
 Tehran Heart Center
 Non-Communicable Diseases Research Center
 Aja University of Medical Sciences
 Ahvaz Jundishapur University of Medical Sciences
 Shahid Beheshti University of Medical Sciences
 School of Medicine
 Imam Khomeini Hospital
 Tehran Arrhythmia Center

Abstract

Background: The cornerstone of the treatment of vasovagal syncope (VVS) is lifestyle modifications; however, some patients incur life-disturbing attacks despite compliance with these treatments which underscores the importance of pharmacological interventions. Methods: In this open-label multi-center randomized controlled trial, we are going to randomize 1375 patients with VVS who had ≥2 syncopal episodes in the last year into three parallel arms with a 2:2:1 ratio to receive midodrine, fludrocortisone, or no medication. All patients will be recommended to drink 2 to 3 liters of fluids per day, consume 10 grams of NaCl per day, and practice counter-pressure maneuvers. In medication arms, patients will start on 5 mg of midodrine TDS or 0.05 mg of fludrocortisone BD. After one week the dosage will be up-titrated to midodrine 30 mg/day and fludrocortisone 0.2 mg/day. Patient tolerance will be the principal guide to dosage adjustments. We will follow-up the patients on 3, 6, 9, and 12 months after randomization. The primary outcome is the time to first syncopal episode. Secondary outcomes include the recurrence rate of VVS, time interval between first and second episodes, changes in quality of life (QoL), and major and minor adverse drug reactions. QoL will be examined by the 36-Item Short Form Survey questionnaire at enrollment and 12 months after randomization. Conclusion: The COMFORTS trial is the first study that aims to make a head-to-head comparison between midodrine and fludrocortisone, against a background of lifestyle modifications for preventing recurrences of VVS and improving QoL in patients with VVS.

Keyword(s)

Medicine

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URI

https://repository.li.mahidol.ac.th/handle/123456789/78101

Collections

Scopus 2021