Compression Stockings for Treating Vasovagal Syncope Trial

Summary

Syncope, a sudden, transient loss of consciousness (TLOC), is a common inconvenience of daily function and quality of life (QoL). The vasovagal syncope (VVS) is the most common type of syncope, which central and peripheral stimuli may trigger syncope by decreasing peripheral vascular resistance, bradycardia, or both. The venous return to the heart is one of these triggers which its reduction may occur due to prolonged standing, hot environment, hypovolemia, or redistribution of blood volume. The compression stockings may reduce syncopal episodes by increasing venous return. Although the use of compression stockings was never assessed in clinical trials, it could be a possible treatment for decreasing VVS recurrences.

Conditions

• Syncope, Vasovagal

Interventions

DEVICE

Compression Stockings with 25-30 mm Hg pressure

The group will have compression stockings with 25-30 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 and how to keep them will be provided for the participants with their compression stockings.

DEVICE

Compression stockings with up to <=10 mm Hg pressure

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 and how to keep them will be provided for the participants with their compression stockings.

BEHAVIORAL

Lifestyle modification

All patients will receive standard treatment of VVS despite their randomization(drink 2-3 liters of fluids, consume 10 grams 120 mmol/day of sodium chloride, and practice counter-pressure maneuvers (squatting, leg crossing, handgrip, and arm-tensing))

Sponsors & Collaborators

• Tehran Arrhythmia Center

  collaborator UNKNOWN

• Rajaie Cardiovascular Medical and Research Center

  collaborator OTHER

• Imam Khomeini Hospital

  collaborator OTHER

• Isfahan University of Medical Sciences

  collaborator OTHER

• Ahvaz Jundishapur University of Medical Sciences

  collaborator OTHER

• Guilan University of Medical Sciences

  collaborator OTHER

• Tehran Heart Center

  lead OTHER

Principal Investigators

• Hamed Tavolinejad, MD · Tehran Heart Center, Tehran University of Medical Sciences

• Amirhossein Poopak, MD · Tehran Heart Center, Tehran University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-14

Primary Completion

2024-10-10

Completion

2024-12-10

Countries

• Iran

Study Locations