Compression Stockings for Treating Vasovagal Syncope Trial (COMFORTS II)
Primary Purpose
Syncope, Vasovagal
Status
Recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Compression Stockings with 25-30 mm Hg pressure
Compression stockings with up to <=10 mm Hg pressure
Lifestyle modification
Sponsored by
About this trial
This is an interventional treatment trial for Syncope, Vasovagal focused on measuring Syncope, Vasovagal, Syncope, Compression stocking, Randomized Clinical Trial
Eligibility Criteria
Inclusion Criteria:
- 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
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 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)
- Presence of a chronic severe illness
- Pregnancy, or intention to become pregnant in the next year
- Unwillingness to participate or to provide informed consent
Sites / Locations
- Tehran Heart CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Compression stockings with 25-30 mm Hg pressure
Compression stockings with up to 10 mm Hg pressure
Arm Description
Compression stockings with 25-30 mm Hg pressure, as long as they could (ideal would be the majority of the time they are upright)
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)
Outcomes
Primary Outcome Measures
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 time to the first syncopal episode
Time from randomization to occurrence of the first episode of vasovagal syncope during the follow-up
Secondary Outcome Measures
The frequency of syncopal episodes
The frequency of syncopal episodes in the follow-up period
The time intervals between recurrent episodes
The time between recurrent episodes of syncope
Patient-reported adverse events
Patient-reported adverse events in the follow-up period
Full Information
NCT ID
NCT05086679
First Posted
October 5, 2021
Last Updated
April 8, 2022
Sponsor
Tehran Heart Center
Collaborators
Tehran Arrhythmia Center, Rajaie Cardiovascular Medical and Research Center, Imam Khomeini Hospital, Isfahan University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Guilan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05086679
Brief Title
Compression Stockings for Treating Vasovagal Syncope Trial
Acronym
COMFORTS II
Official Title
Compression Stockings for Treating Vasovagal Syncope (COMFORTS II) Trial; a Double Blind, Multi-center Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
October 10, 2024 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran Heart Center
Collaborators
Tehran Arrhythmia Center, Rajaie Cardiovascular Medical and Research Center, Imam Khomeini Hospital, Isfahan University of Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Guilan University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The COMFORTS II study is designed as a multicenter, longitudinal, double blind, parallel design RCT to assess the beneficial effect of compression stockings for preventing recurrences of VVS. The participants will be treated by the standard treatment of VVS, and then they will be randomized into two groups (1:1 ratio) to use compression stockings, one group with 25-30 mm Hg pressure and the other one with <= 10 mmHg pressure, Randomization and allocation concealment will be done by the primary investigators (www.comfortstrial.com). To balance participant enrolment, participating centers will stratify the randomization block. The enrolling physicians will be blinded to the randomization to minimize the selection bias. Hence, the randomization code will not be revealed till the patient has been enrolled, and the baseline features and consent form have been uploaded.
The syncope Unit of Tehran Heart Center (SUTHC), Tehran University of Medical Sciences is the primary investigation site (same as COMFORTS I trial). Seven study centers across Iran declared their commitment to participate in this study. After randomization, participants will be allocated their treatment as one group will have compression stockings with 25-30 mm Hg pressure and in the control group pressure will be limited up to <=10 mmHg, which elastic compression stockings will be sent to patients by post. Participants will be asked to use compression stockings as long as they could (ideal would be the majority of the time they are upright). Adherence of patients to the use of compression stockings will be daily with predefined forms given to patients after randomization. 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. All patients will receive standard treatment of VVS despite their randomization. According to syncope guidelines, patients will learn to 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
After six months of follow-up for 50% of the study participants, event rates will be assessed by the data and safety monitoring board (DSMB) and the sample size can be adjusted based on DSMB guidance
Data safety and monitoring board (DSMB):
a. Roles: i. Monitoring data quality and completeness, as well as timeliness of enrollment, visit, and follow-up, ii. Overseeing adherence to trial protocol and providing feedback in documented reports to the trial committee iii. Overseeing performance of individual centers, and providing feedback in documented reports to the trial committee iv. Monitoring patient safety and their current treatment, and recommending changes in therapies for individuals subjects if needed, v. Advising adjustments to the sample size after interim analysis of data upon completion of six months of follow-up for half of the study sample size, vi. Monitoring scientific or therapeutic developments in the field, and in case of major developments providing updated recommendations on the ethics of the study.
b. Meetings: i. At the start of enrollment ii. Every three months after beginning of enrollment until the final follow-up iii. After formal analysis of the data has been performed iv. The chair of DSMB may call for additional meetings
c. Members: i. Chair: Dr. Haleh Ashraf (Sina Hospital); The chair of DSMB is responsible for conducting meetings, and may add members to the DSMB at her own discretion. ii. Mohammad-Reza Malekpour (Non-communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute) iii. Maryam Masoudi (Roozbeh Psychiatric Hospital)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
Syncope, Vasovagal, Syncope, Compression stocking, Randomized Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Compression stockings with 25-30 mm Hg pressure
Arm Type
Active Comparator
Arm Description
Compression stockings with 25-30 mm Hg pressure, as long as they could (ideal would be the majority of the time they are upright)
Arm Title
Compression stockings with up to 10 mm Hg pressure
Arm Type
Sham Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Compression Stockings with 25-30 mm Hg pressure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Compression stockings with up to <=10 mm Hg pressure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
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))
Primary Outcome Measure Information:
Title
The proportion of participants with recurrence of VVS
Description
The proportion of participants with recurrence of VVS to all participants in their arm of treatment during the follow-up
Time Frame
The follow-up continues for 12 months after randomization
Title
The time to the first syncopal episode
Description
Time from randomization to occurrence of the first episode of vasovagal syncope during the follow-up
Time Frame
The follow-up continues for 12 months after randomization
Secondary Outcome Measure Information:
Title
The frequency of syncopal episodes
Description
The frequency of syncopal episodes in the follow-up period
Time Frame
The follow-up continues for 12 months after randomization
Title
The time intervals between recurrent episodes
Description
The time between recurrent episodes of syncope
Time Frame
The follow-up continues for 12 months after randomization
Title
Patient-reported adverse events
Description
Patient-reported adverse events in the follow-up period
Time Frame
The follow-up continues for 12 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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 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)
Presence of a chronic severe illness
Pregnancy, or intention to become pregnant in the next year
Unwillingness to participate or to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masih Tajdini, MD
Phone
+982188029640
Email
mtajdini@sina.tums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamed Tavolinejad, MD
Organizational Affiliation
Tehran Heart Center, Tehran University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amirhossein Poopak, MD
Organizational Affiliation
Tehran Heart Center, Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Tehran Heart Center
City
Tehran
ZIP/Postal Code
1411713138
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masih Tajdini, MD
Phone
+982188029640
Email
mtajdini@sina.tums.ac.ir
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data is not publicly available due to privacy/ethical restrictions. The data can be shared upon reasonable request to the trial committee.
Citations:
PubMed Identifier
33346809
Citation
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.
Results Reference
background
PubMed Identifier
33689731
Citation
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.
Results Reference
background
Links:
URL
http://comfortstrial.com/
Description
Description The COMFORTS Trial website
Learn more about this trial
Compression Stockings for Treating Vasovagal Syncope Trial
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