COMpression stockings FOR Treating vasovagal Syncope (COMFORTS-II) trial

Not Applicable

Recruiting

• Conditions: vasovagal syncope.; Syncope and collapse

• Registration Number: IRCT20220515054863N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

Patients with 18 = age = 65 years
Vasovagal syncope as the cause of transient loss of conscious confirmed by Clinical diagnosis AndCalgary syncope system score (CSSS) =-2
=2 episodes of VVS during the last year
Capability of giving informed consent

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.