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 - 26/05/21

Doi : 10.1016/j.ahj.2021.03.002

Arya Aminorroaya, MD, MPH ^a,^b,^{^{†
These authors contributed equally as co-first authors.}}, Hamed Tavolinejad, MD ^a,^{^{†
These authors contributed equally as co-first authors.}}, Saeed Sadeghian, MD ^a, Arash Jalali, PhD ^a, Farshid Alaeddini, MD, PhD ^a, Zahra Emkanjoo, MD ^c, Reza Mollazadeh, MD ^d, Ali Bozorgi, MD ^a, Saeed Oraii, MD ^e, Mohamadreza Kiarsi, MD ^f, Javad Shahabi, MD ^g, Mohammad Ali Akbarzadeh, MD ^h, Behzad Rahimi, MD ⁱ, Adel Joharimoghadam, MD ^j, Abolfazl Mohsenizade, MD ^j, Roghayeh Mohammadi, MD ^a, Alireza Oraii, MD ^a, Hamid Ariannejad, MD ^a, Sanatcha Apakuppakul, MD ^k, Tachapong Ngarmukos, MD ^k,^⁎ , Masih Tajdini, MD ^a,^⁎
^a Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran
^b Non-Communicable Disease Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran
^c Cardiac Electrophysiology Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran
^d Department of Cardiology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
^e Tehran Arrhythmia Center, 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 Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
ⁱ Department of Cardiology, School of Medicine, Urmia University of Medical Sciences, Urmia, Iran
^j Department of Cardiology, AJA University of Medical Sciences, Tehran, Iran
^k Cardiac Arrhythmia Service, Cardiovascular Disease Section, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

^⁎Reprint requests: Masih Tajdini, MD, Assistant Professor of Cardiology, Tehran Heart Center, Jalal Al Ahmad, and North Kargar Intersection, Tehran, Iran.Assistant Professor of CardiologyTehran Heart CenterJalal Al Ahmad, and North Kargar IntersectionTehranIran^⁎⁎Reprint requests: Tachapong Ngarmukos, MD, Clinical Cardiac Electrophysiologist, Cardiac Arrhythmia Service, Cardiovascular Disease Section, Department of Internal Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, 270 Rama VI Road, Ratchathewi, Bangkok 10400, ThailandClinical Cardiac ElectrophysiologistCardiac Arrhythmia ServiceCardiovascular Disease SectionDepartment of Internal MedicineFaculty of MedicineRamathibodi HospitalMahidol University270 Rama VI Road, RatchathewiBangkok10400Thailand

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.

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Vol 237

P. 5-12 - juillet 2021 Retour au numéro

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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 - 26/05/21

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