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

Efficacy of compression stockings for treating recurrent vasovagal syncope: a triple-blind, multi-center, randomized controlled trial (COMFORTS-II)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220515054863N1
Enrollment
268
Registered
2022-10-29
Start date
2022-04-01
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vasovagal syncope. Syncope and collapse

Interventions

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 com

Sponsors

Tehran University of Medical Sciences
Lead Sponsor
Right Arian Farmed
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasih Tajdini

Tehran University of Medical Sciences

mtajdini@sina.tums.ac.ir+98 21 8802 9600

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026