Compression Garments in the Community With POTS

NCT04881318 | Recruiting

• 1 other identifier: REB20-2224
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Compression Garments are a commonly prescribed treatment in Postural Orthostatic Tachycardia Syndrome (POTS). The effectiveness of a proof-of-concept compression garment has been demonstrated in an acute laboratory setting. It is not known if commercially available compression garments that participants wear in their every day lives are effective at improving heart rate and reducing symptoms in POTS. This trial will evaluate the use of commercially available waist-high and abdominal compression garments in adults diagnosed with POTS in a community setting.

Conditions

Postural Orthostatic Tachycardia Syndrome

Outcome Measures

Primary Outcomes (2)

• WHC Heart Rate

  The primary outcome is the delta HR (standing HR - supine HR) in orthostatic vital signs (OVS) #1 (prior to the WHC) and OVS #2 (30min after WHC is applied), in the "Without Medication" phase.

  10 minutes

• AC Heart Rate

  The primary outcome is the delta HR (standing HR - supine HR) in orthostatic vital signs (OVS) #1 (prior to the AC) and OVS #2 (30min after AC is applied), in the "Without Medication" phase.

  10 minutes

Secondary Outcomes (5)

• Heart Rate - End of Study Day (WHC)

  10 minutes

• Heart Rate - WHC and Medication

  10 minutes

• Heart Rate - WHC and AC

  10 minutes

• Heart Rate - End of Study Day (AC)

  10 minutes

• Heart Rate - AC and Medication

  10 minutes

Study Arms (4)

Waist-High Compression Tights and Medications

EXPERIMENTAL

Participants will wear the waist-high compression garment while taking their regularly prescribed medications. This arm will evaluate the effects of waist-high compression garment treatment together with medications that modulate heart rate and blood pressure. This arm will also include control measurements before the garment is put on and after the garment is removed.

Other: Waist-High Compression Tights; Drug: Medications that modulate heart rate and blood pressure

Waist-High Compression Tights and No Medications

EXPERIMENTAL

Participants will wear the waist-high compression garment while holding their regular medications that modulate heart rate and blood pressure (beta-blockers, midodrine, ivabradine, stimulants). This arm will look at the effectiveness of waist-high compression without medications. This arm will also include control measurements before the garment is put on and after the garment is removed.

Other: Waist-High Compression Tights

Abdominal Compression Garments and Medications

EXPERIMENTAL

Participants will wear the abdominal compression garment while taking their regularly prescribed medications. This arm will evaluate the effects of abdominal compression garment treatment together with medications that modulate heart rate and blood pressure. This arm will also include control measurements before the garment is put on and after the garment is removed.

Other: Abdominal Compression Garments; Drug: Medications that modulate heart rate and blood pressure

Abdominal Compression Garments and No Medications

EXPERIMENTAL

Participants will wear the abdominal compression garment while holding their regular medications that modulate heart rate and blood pressure (beta-blockers, midodrine, ivabradine, stimulants). This arm will look at the effectiveness of abdominal compression without medications. This arm will also include control measurements before the garment is put on and after the garment is removed.

Other: Abdominal Compression Garments

Interventions

Waist-High Compression Tights OTHER

Waist-high compression tights providing 15-40 mmHg of pressure.

Also known as: Full Length Compression Tights

Waist-High Compression Tights and Medications; Waist-High Compression Tights and No Medications

Abdominal Compression Garments OTHER

Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.

Also known as: Abdominal shapewear, compression shorts

Abdominal Compression Garments and Medications; Abdominal Compression Garments and No Medications

Medications that modulate heart rate and blood pressure DRUG

Medications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants.

Abdominal Compression Garments and Medications; Waist-High Compression Tights and Medications

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physician diagnosis of Postural Tachycardia Syndrome (POTS)
• Resident of Canada
• Owns waist-high compression garment: medical grade or commercially available tights with a pressure rating provided (e.g. 15-18 mmHg, 20-30 mmHg, 30-40 mmHg)
• Optional Sub-Study: owns an abdominal compression garment (e.g. abdominal shapewear, waist high shorts)
• Able to participate in a 4-day study (2x2 day segments with a 5-day washout period)

You may not qualify if:

• Overt cause for postural tachycardia (i.e., acute dehydration, thyroid disease) that precludes POTS diagnosis
• Not a resident of Canada
• Participants with somatization or severe anxiety symptoms will be excluded
• Pregnant (self-reported)
• Inability to tolerate compression garments for the duration of the study
• Does not own a waist-high compression garment
• Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

Related Publications (2)

• Bourne KM, Karalasingham K, Siddiqui T, Mammarella B, Patel A, Exner DV, Sheldon RS, Raj SR. Abdominal-only Compression Garments Reduce Orthostatic Tachycardia and Improve Symptoms in Patients With Postural Orthostatic Tachycardia Syndrome. Can J Cardiol. 2025 Dec 1:S0828-282X(25)01481-3. doi: 10.1016/j.cjca.2025.11.038. Online ahead of print.

  PMID: 41338488 DERIVED

• Bourne KM, Karalasingham K, Siddiqui T, Patel A, Exner D, Sheldon R, Raj SR. A Community-Based Trial of Commercially Available Compression Tights in Patients With Postural Orthostatic Tachycardia Syndrome. JACC Clin Electrophysiol. 2025 Jan;11(1):179-190. doi: 10.1016/j.jacep.2024.09.033. Epub 2024 Nov 27.

  PMID: 39614865 DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Satish M Raj, MD MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate M Bourne, BSc

CONTACT

403-210-7401; autonomic.research@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to mask participants to the compression garment intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will investigate the effects waist high compression garments and medications compared to waist-high compression garments and medications held. Participants will cross-over and complete both arms. If participants participate in the abdominal compression sub-study, the order of waist-high compression - abdominal compression will also be randomized.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 11, 2021
• Study Start: May 17, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)