Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1375 participants
INTERVENTIONAL
2020-11-19
2023-12-31
Brief Summary
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The cornerstone of the treatment of vasovagal syncope (VVS), the most common type of syncope, is lifestyle modifications and patient education to avoid potential triggers of syncope. These recommendations alleviate vasovagal spells in many patients; however, some patients experience life-disturbing vasovagal attacks despite compliance with these modifications. This fact underscores the importance of efficient pharmacological interventions as well.
Currently, there is an ongoing controversy about the efficacy of midodrine and fludrocortisone as adjunct pharmacological interventions for the prevention of VVS. In the COMFORTS trial, we are going to evaluate the efficacy of midodrine, fludrocortisone, and lifestyle modifications for prevention of vasovagal attacks in patients with VVS.
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Detailed Description
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Methods: In the COMFORTS trial, a multi-center randomized controlled trial, 1375 patients with VVS will be randomized into three parallel arms with a 2:2:1 ratio to receive midodrine, fludrocortisone, or just lifestyle modifications. All patients will receive recommendations for lifestyle modifications. In the pharmacological intervention arms, patients will receive 5 mg of midodrine three times a day or 0.1 mg of fludrocortisone twice daily. In case of intolerance, the dosage will be cut by half. If the patient does not tolerate even the reduced dosage, the medication will be discontinued and the patient will be advised to use compression garments, practice tilt training exercises, or switch to the other medication. The patients will be followed on 3, 6, and 12 months after dose stabilization. Primary efficacy outcomes of the study is the time to the first syncopal episode. The secondary efficacy outcome are the recurrence rate of syncope, number of syncopal episodes and the quality of life of the patients which will be assessed by the 36-Item Short Form Survey questionnaire at the enrollment and 12 months after dose stabilization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Midodrine
10 mg midodrine three times a day
Midodrine Hydrochloride Tablets
Patients will be started on 5 mg Midodrine three times a day and after one week the dosage will be up-titrated to 10 mg three times a day and continued for 12 months. They will receive the medication at four-hour intervals upon rising in the morning (the last dose should not be taken later than 6 PM). In case of intolerance, the dosage will be reduced to 2.5 mg three times a day. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting).
Lifestyle modification
Patients will be recommended to drink 2 to 3 liters of fluid per day, consume 10 grams of salt per day, and practice counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting) for 12 months.
Fludrocortisone
0.1 mg fludrocortisone two times a day
Fludrocortisone Acetate Tablets
Patients will be started on 0.05 mg of fludrocortisone twice daily and after one week the dosage will be up-titrated to 0.1 mg fludrocortisone twice daily taken for 12 months. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting). In this arm, potassium levels will be checked 7-14 days after dose stabilization.
Lifestyle modification
Patients will be recommended to drink 2 to 3 liters of fluid per day, consume 10 grams of salt per day, and practice counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting) for 12 months.
Lifestyle modification
Education, salt and water intake, counter-pressure maneuvers
Lifestyle modification
Patients will be recommended to drink 2 to 3 liters of fluid per day, consume 10 grams of salt per day, and practice counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting) for 12 months.
Interventions
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Midodrine Hydrochloride Tablets
Patients will be started on 5 mg Midodrine three times a day and after one week the dosage will be up-titrated to 10 mg three times a day and continued for 12 months. They will receive the medication at four-hour intervals upon rising in the morning (the last dose should not be taken later than 6 PM). In case of intolerance, the dosage will be reduced to 2.5 mg three times a day. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting).
Fludrocortisone Acetate Tablets
Patients will be started on 0.05 mg of fludrocortisone twice daily and after one week the dosage will be up-titrated to 0.1 mg fludrocortisone twice daily taken for 12 months. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting). In this arm, potassium levels will be checked 7-14 days after dose stabilization.
Lifestyle modification
Patients will be recommended to drink 2 to 3 liters of fluid per day, consume 10 grams of salt per day, and practice counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting) for 12 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥2 episodes of syncope during the last year
* Medication-naïve or have at least a 2-week washout period prior to randomization
* The capability of giving informed consent
* Signed written informed consent
Exclusion Criteria
* Cardiac rhythm disorders including ventricular tachycardia, long QT syndrome, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, complete heart block, and any conduction abnormality on electrocardiogram
* Severe valvular heart disease
* Hypertrophic cardiomyopathy
* Cardiac systolic dysfunction (ejection fraction≤40%)
* Obstructive coronary artery disease
* Hypertension
* Diabetes mellitus
* Cirrhosis
* Renal failure stage≥3
* Known intolerance or hypersensitivity to midodrine or fludrocortisone
* Urinary retention
* Pheochromocytoma
* Thyrotoxicosis
* Glaucoma
* Previous use of midodrine or fludrocortisone for treatment of VVS or another condition
* Pregnancy or breastfeeding
18 Years
65 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Rajaie Cardiovascular Medical and Research Center
OTHER
Tehran Arrhythmia Center
UNKNOWN
Imam Khomeini Hospital
OTHER
AJA University of Medical Sciences
OTHER
Urmia University of Medical Sciences
OTHER
Isfahan University of Medical Sciences
OTHER
Shahid Beheshti University of Medical Sciences
OTHER
Ahvaz Jundishapur University of Medical Sciences
OTHER
Tehran Heart Center
OTHER
Responsible Party
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Masih Tajdini, MD
Assistant Professor of Cardiology
Principal Investigators
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Arash Jalali, PhD
Role: STUDY_DIRECTOR
Tehran Heart Center, Tehran University of Medical Sciences
Arya Aminorroaya, MD, MPH
Role: STUDY_DIRECTOR
Tehran Heart Center, Tehran University of Medical Sciences
Hamed Tavolinejad, MD
Role: STUDY_DIRECTOR
Tehran Heart Center, Tehran University of Medical Sciences
Saeed Sadeghian, MD
Role: STUDY_CHAIR
Tehran Heart Center, Tehran University of Medical Sciences
Locations
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Tehran Heart Center
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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References
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Aminorroaya A, Tavolinejad H, Sadeghian S, Jalali A, Alaeddini F, Emkanjoo Z, Mollazadeh R, Bozorgi A, Oraii S, Kiarsi M, Shahabi J, Akbarzadeh MA, Rahimi B, Joharimoghadam A, Mohsenizade A, Mohammadi R, Oraii A, Ariannejad H, Apakuppakul S, Ngarmukos T, Tajdini M. 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. Am Heart J. 2021 Jul;237:5-12. doi: 10.1016/j.ahj.2021.03.002. Epub 2021 Mar 6.
Sadeghian S, Aminorroaya A, Tajdini M. The Syncope Unit of Tehran Heart Center. Eur Heart J. 2021 Jan 7;42(2):148-150. doi: 10.1093/eurheartj/ehaa532. No abstract available.
Other Identifiers
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99-2-408-49493
Identifier Type: -
Identifier Source: org_study_id
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