Compression Stockings for Treating Vasovagal Syncope Trial

NCT05086679 | Unknown DMC

• 1 other identifier: 1400-2-101-54781
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Syncope, Vasovagal; Syncope; Compression stocking; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (2)

• The proportion of participants with recurrence of VVS

  The proportion of participants with recurrence of VVS to all participants in their arm of treatment during the follow-up

  The follow-up continues for 12 months after randomization

• The time to the first syncopal episode

  Time from randomization to occurrence of the first episode of vasovagal syncope during the follow-up

  The follow-up continues for 12 months after randomization

Secondary Outcomes (3)

• The frequency of syncopal episodes

  The follow-up continues for 12 months after randomization

• The time intervals between recurrent episodes

  The follow-up continues for 12 months after randomization

• Patient-reported adverse events

  The follow-up continues for 12 months after randomization

Study Arms (2)

Compression stockings with 25-30 mm Hg pressure

ACTIVE COMPARATOR

Compression stockings with 25-30 mm Hg pressure, as long as they could (ideal would be the majority of the time they are upright)

Device: Compression Stockings with 25-30 mm Hg pressure; Behavioral: Lifestyle modification

Compression stockings with up to 10 mm Hg pressure

SHAM COMPARATOR

Compression stockings with up to \<=10 mm Hg pressure, as long as they could (ideal would be the majority of the time they are upright)

Device: Compression stockings with up to <=10 mm Hg pressure; Behavioral: Lifestyle modification

Interventions

Compression Stockings with 25-30 mm Hg pressure DEVICE

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.

Compression stockings with 25-30 mm Hg pressure

Compression stockings with up to <=10 mm Hg pressure DEVICE

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.

Compression stockings with up to 10 mm Hg pressure

Lifestyle modification BEHAVIORAL

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))

Compression stockings with 25-30 mm Hg pressure; Compression stockings with up to 10 mm Hg pressure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 18≤age≤65
• VVS as the cause of TLOC confirmed by Clinical diagnosis And CSSS ≥-2
• ≥2 episodes of VVS during the last year
• The capability of giving informed consent
• Signed written informed consent

You may not qualify if:

• 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 midodrine or fludrocortisone
• Cardiac rhythm disorders including ventricular tachycardia, long QT syndrome, Brugada syndrome, ARVC, CHB, 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 ECS by a health-care provider, or other indication for ECS use
• Foot ulcers and diabetic foot
• Chronic venous insufficiency
• Renal failure stage ≥3 (eGFR \<60 mL/min/1.73 m2)

Sponsors & Collaborators

• Tehran Heart Center: lead
• Tehran Arrhythmia Center: collaborator
• Rajaie Cardiovascular Medical and Research Center: collaborator
• Imam Khomeini Hospital: collaborator
• Isfahan University of Medical Sciences: collaborator
• Ahvaz Jundishapur University of Medical Sciences: collaborator
• Guilan University of Medical Sciences: collaborator

Study Sites (1)

Tehran Heart Center

Tehran, 1411713138, Iran

RECRUITING

Related Publications (2)

• 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.

  PMID: 33346809 BACKGROUND

• 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.

  PMID: 33689731 BACKGROUND

MeSH Terms

Conditions

Syncope, Vasovagal; Syncope

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Compression Bandages; Bandages; Equipment and Supplies

Study Officials

• Hamed Tavolinejad, MD

  Tehran Heart Center, Tehran University of Medical Sciences

  STUDY DIRECTOR

• Amirhossein Poopak, MD

  Tehran Heart Center, Tehran University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Masih Tajdini, MD

CONTACT

+982188029640; mtajdini@sina.tums.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Cardiology

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 21, 2021
• Study Start: March 14, 2022
• Primary Completion: October 10, 2024
• Study Completion: December 10, 2024
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)