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IRCT20220515054863N1 IRCT 2022-10-29 Tehran University of Medical Sciences COMpression stockings FOR Treating vasovagal Syncope (COMFORTS-II) trial COMFORTS-II: COMpression stockings FOR Treating vasovagal Syncope Efficacy of compression stockings for treating recurrent vasovagal syncope: a triple-blind, multi-center, randomized controlled trial (COMFORTS-II) 2022-04-01 anticipated 268 Complete https://irct.ir/trial/63576 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible participants will be randomized 1:1 to two parallel treatment and control groups. The random sequence will be generated by computer software (R software, blockrand package) using permuted block randomization, in block sizes of 2, 4, 6, 8. To balance participant enrollment in each study recruitment site, randomization is stratified based on the trial sites. A separate randomization sequence will be generated for each study center (each stratum). Since seven centers will be participating in this study, seven sequences will be generated. Allocation of the random code will be centralized and conducted online through the study website (www.comfortstrial.com). Enrolling physicians will upload baseline data, informed consent confirmation, and the measured size of compression stockings, and after completion and confirmation of recruitment forms, the website will allocate a random code for the patient. A pair of compression stockings with the correct size and from the appropriate group (treatment or control) will then be posted to the patient from Tehran Heart Center. Allocation concealment is ensured since the recruiting physician and patients are blinded to the treatment group, randomization is web-based and centralized, and a random code would not be allocated until recruitment is confirmed, Blinding description: The compression stockings in treatment and control groups are identical in appearance and touch, and are made from the same material. The stocking will be provided to patients in identical unlabelled boxing. The only difference between compression stockings would be the pressure to the lower extremity. This is not expected to affect blinding, since eligible patients would not be using compression stocking before the trial and would not be familiar with the amount of pressure they experience. To assess blinding of patients during the study, participants will be asked to guess their randomly allocated treatment group at the last follow-up. The proportion of correct responses will be compared to the expected rate of random correct guesses (50%). Blinding will be achieved with centralized web-based randomization, and similarity in appearance of treatments. In addition to patients, the primary investigator, recruiting physicians, nurse researcher that gather baseline data, and outcome assessors will all be blinded to the randomly allocated group. Moreover, statisticians who will analyze the data for the final report in the manuscript will be blinded until finalization of results. N/A vasovagal syncope. Intervention 1: Intervention group: Compression stockings with 25-30mm Hg pressure for one year. The group will have compression stockings with25-30 mm Hg pressure. All the participants' size for compression stocking will be measured at the first visit. Three points will be measured: below and above their knees and above their ankle. Subsequently, Right Arian Farmed Co (Tehran, Iran) will provide compression stockings for patients based on their sizes. Participants will be asked to use compression stockings as long as they could (ideal would be the majority of the time they are upright). In addition, a CD included some videos and booklets about instructions on how to wear CS (compression stocking) and how to keep them will be provided for the participants with their compression stockings. Intervention 2: Control group: Compression stockings with up to 10 mm Hg pressure for one year. The group will have compression stockings with up to 10 mm Hg pressure. All the participants' size for compression stocking will be measured at the first visit. Three points will be measured: below and above their knees and above their ankle. Subsequently, Right Arian Farmed Co (Tehran, Iran) will provide compression stockings for patients based on their sizes. Participants will be asked to use compression stockings as long as they could (ideal would be the majority of the time they are upright). In addition, a CD included some videos and booklets about instructions on how to wear CS(compression stocking) and how to keep them will be provided for the participants with their compression stockings. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Masih Tajdini
Tehran Heart Center, Kargar st
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 mtajdini@sina.tums.ac.ir Tehran University of Medical Sciences scientific Masih Tajdini
Tehran Heart Center, Kargar st
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 mtajdini@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with 18 ≤ age ≤ 65 years Vasovagal syncope as the cause of transient loss of conscious confirmed by Clinical diagnosis And Calgary syncope system score (CSSS) ≥-2 ≥2 episodes of VVS during the last year Capability of giving informed consent 18 years 65 years Both Orthostatic hypotension (decrease in BP ≥20/10 mmHg after 5-minute stand test) Postural tachycardia (increase in heart rate ≥30 bpm after 5-minute stand test) Carotid sinus hypersensitivity (ventricular pause >3 or decrease in BP > 50 mmHG after carotid sinus massage, performed in patients 40 years or older) History of Seizure Currently using medications for treatment of vasovagal syncope Cardiac rhythm disorders including ventricular tachycardia, long QT syndrome, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, complete heart block, or any conduction abnormality on ECG Severe valvular heart disease Hypertrophic cardiomyopathy Cardiac systolic dysfunction (ejection fraction ≤40%) Obstructive coronary artery disease Cardiac implantable electronic devices Prior recommendation of compression stocking by a health-care provider, or other indication for compression stocking use Foot ulcers and diabetic foot Chronic venous insufficiency Renal failure stage ≥3 (eGFR <60 mL/min/1.73 m2) Presence of a chronic severe illness Pregnancy, or intention to become pregnant in the next year Unwillingness to participate or to provide informed consent R55 Syncope and collapse Treatment - Other Treatment - Other Intervention group: Compression stockings with 25-30mm Hg pressure for one year. The group will have compression stockings with25-30 mm Hg pressure. All the participants' size for compression stocking will be measured at the first visit. Three points will be measured: below and above their knees and above their ankle. Subsequently, Right Arian Farmed Co (Tehran, Iran) will provide compression stockings for patients based on their sizes. Participants will be asked to use compression stockings as long as they could (ideal would be the majority of the time they are upright). In addition, a CD included some videos and booklets about instructions on how to wear CS (compression stocking) and how to keep them will be provided for the participants with their compression stockings Control group: Compression stockings with up to 10 mm Hg pressure for one year. The group will have compression stockings with up to 10 mm Hg pressure. All the participants' size for compression stocking will be measured at the first visit. Three points will be measured: below and above their knees and above their ankle. Subsequently, Right Arian Farmed Co (Tehran, Iran) will provide compression stockings for patients based on their sizes. Participants will be asked to use compression stockings as long as they could (ideal would be the majority of the time they are upright). In addition, a CD included some videos and booklets about instructions on how to wear CS(compression stocking) and how to keep them will be provided for the participants with their compression stockings. Proportion of participants with recurrence of vasovagal syncope. Timepoint: Every three months until one year (three, six, nine, and twelve months after randomization). Method of measurement: Telephone follow-up questionnaire. Time to first syncopal episode. Timepoint: Every three months until one year (three, six, nine, and twelve months after randomization). Method of measurement: Telephone follow-up questionnaire. Frequency of vasovagal syncopal episodes. Timepoint: Every three months until one year (three, six, nine, and twelve months after randomization). Method of measurement: Telephone follow-up questionnaire. Time intervals between recurrent vasovagal syncope episodes during follow-up. Timepoint: Every three months until one year (three, six, nine, and twelve months after randomization). Method of measurement: Telephone follow-up questionnaire. Incidence of any adverse effect after using compression stockings. Timepoint: Every three months until one year (three, six, nine, and twelve months after randomization). Method of measurement: Telephone follow-up questionnaire. Right Arian Farmed Tehran University of Medical Sciences Right Arian Farmed Approved 2021-09-28 Ethics Committees of Tehran Heart Center Tehran Heart Center, Kargar st Tehran Tehran Iran (Islamic Republic of)