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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 Publisher Pubmed



Aminorroaya A1, 2 ; Tavolinejad H1 ; Sadeghian S1 ; Jalali A1 ; Alaeddini F1 ; Emkanjoo Z3 ; Mollazadeh R4 ; Bozorgi A1 ; Oraii S5 ; Kiarsi M6 ; Shahabi J7 ; Akbarzadeh MA8 ; Rahimi B9 ; Joharimoghadam A10 Show All Authors
Authors
  1. Aminorroaya A1, 2
  2. Tavolinejad H1
  3. Sadeghian S1
  4. Jalali A1
  5. Alaeddini F1
  6. Emkanjoo Z3
  7. Mollazadeh R4
  8. Bozorgi A1
  9. Oraii S5
  10. Kiarsi M6
  11. Shahabi J7
  12. Akbarzadeh MA8
  13. Rahimi B9
  14. Joharimoghadam A10
  15. Mohsenizade A10
  16. Mohammadi R1
  17. Oraii A1
  18. Ariannejad H1
  19. Apakuppakul S11
  20. Ngarmukos T11
  21. Tajdini M1
Show Affiliations
Authors Affiliations
  1. 1. Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran
  2. 2. Non-Communicable Disease Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Cardiac Electrophysiology Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Cardiology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Tehran Arrhythmia Center, 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. Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  9. 9. Department of Cardiology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran
  10. 10. Department of Cardiology, AJA University of Medical Sciences, Tehran, Iran
  11. 11. Cardiac Arrhythmia Service, Cardiovascular Disease Section, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

Source: American Heart Journal Published:2021


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. © 2021 Elsevier Inc.
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