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

dc.contributor.authorArya Aminorroayaen_US
dc.contributor.authorHamed Tavolinejaden_US
dc.contributor.authorSaeed Sadeghianen_US
dc.contributor.authorArash Jalalien_US
dc.contributor.authorFarshid Alaeddinien_US
dc.contributor.authorZahra Emkanjooen_US
dc.contributor.authorReza Mollazadehen_US
dc.contributor.authorAli Bozorgien_US
dc.contributor.authorSaeed Oraiien_US
dc.contributor.authorMohamadreza Kiarsien_US
dc.contributor.authorJavad Shahabien_US
dc.contributor.authorMohammad Ali Akbarzadehen_US
dc.contributor.authorBehzad Rahimien_US
dc.contributor.authorAdel Joharimoghadamen_US
dc.contributor.authorAbolfazl Mohsenizadeen_US
dc.contributor.authorRoghayeh Mohammadien_US
dc.contributor.authorAlireza Oraiien_US
dc.contributor.authorHamid Ariannejaden_US
dc.contributor.authorSanatcha Apakuppakulen_US
dc.contributor.authorTachapong Ngarmukosen_US
dc.contributor.authorMasih Tajdinien_US
dc.contributor.otherRajaie Cardiac Electrophysiology Research Centeren_US
dc.contributor.otherRamathibodi Hospitalen_US
dc.contributor.otherCardiac Rehabilitation Research Center, Isfahan UMSen_US
dc.contributor.otherTehran Heart Centeren_US
dc.contributor.otherNon-Communicable Diseases Research Centeren_US
dc.contributor.otherAja University of Medical Sciencesen_US
dc.contributor.otherAhvaz Jundishapur University of Medical Sciencesen_US
dc.contributor.otherShahid Beheshti University of Medical Sciencesen_US
dc.contributor.otherSchool of Medicineen_US
dc.contributor.otherImam Khomeini Hospitalen_US
dc.contributor.otherTehran Arrhythmia Centeren_US
dc.date.accessioned2022-08-04T09:20:30Z
dc.date.available2022-08-04T09:20:30Z
dc.date.issued2021-07-01en_US
dc.description.abstractBackground: 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.en_US
dc.identifier.citationAmerican Heart Journal. Vol.237, (2021), 5-12en_US
dc.identifier.doi10.1016/j.ahj.2021.03.002en_US
dc.identifier.issn10976744en_US
dc.identifier.issn00028703en_US
dc.identifier.other2-s2.0-85103736099en_US
dc.identifier.urihttps://repository.li.mahidol.ac.th/handle/123456789/78101
dc.rightsMahidol Universityen_US
dc.rights.holderSCOPUSen_US
dc.source.urihttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85103736099&origin=inwarden_US
dc.subjectMedicineen_US
dc.titleComparison of Outcomes with Midodrine and Fludrocortisone for Objective Recurrence in Treating Syncope (COMFORTS trial): Rationale and design for a multi-center randomized controlled trialen_US
dc.typeArticleen_US
dspace.entity.typePublication
mu.datasource.scopushttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85103736099&origin=inwarden_US

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