Compression Garments in the Community With POTS

NCT ID: NCT04881318

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2024-12-31

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.

Detailed Description

Current treatment of Postural Orthostatic Tachycardia Syndrome (POTS) involves pharmacological and non-pharmacological intervention including salt and fluid loading, exercise, physical countermanuevers, and compression garments. Lower extremity compression garments provide mechanical external pressure to the blood vessels in the legs, thighs and abdomen, shifting blood back to the central circulation to increase preload and stroke volume. With increased stroke volume, cardiac output is maintained without excessive tachycardia. Compression garments are commonly prescribed as a non-pharmacological treatment in POTS, but previously little evidence validated their use. A recent proof-of-concept compression garment study performed by our research lab demonstrated significant HR and symptom reductions with compression, with adult POTS patients in an acute laboratory setting. The effectiveness of commercially available compression garments in a community setting in POTS patients is not known.

In this study, the researchers will use commercially or medically (by prescription) available waist-high compression garments (WHC) that POTS patients use in their daily life, to evaluate compression as a viable long-term treatment option. Additionally, the researchers will perform an optional sub-study of abdominal compression garments (AC), evaluating their effectiveness. Results from this study will be used to inform the practicality and effectiveness of compression garments in the community setting. These findings could rapidly translate to the clinical setting and improve patient care.

Primary Hypothesis: Body compression with commercially available WHC will acutely reduce orthostatic tachycardia, when compared to no compression, in a community setting.

Sub-Study Hypothesis: Body compression with commercially available AC will acutely reduce orthostatic tachycardia, when compared to no compression, in a community setting.

The participant will complete the study in a community setting. The participant will be provided with the study supplies including a Holter monitor to wear during the study. The duration of the study will be up to 4 days in total. The "With Medications" phase is 2 days and the "Without Medications" phase is 2 days. The first randomization is whether to do the WHC studies first after medications have been held for at least 24h or without holding the medications. If the participant will be in the AC Sub-Studies, then they will do those studies during the same window of holding medications (or not) as the WHC study. The second randomization would determine the order of WHC-AC vs. AC-WHC during each window

For each study day, there will be a total of 4 standing tests. Participants will first put on the Holter monitor at the beginning of the study day. The first standing test (OVS #1) will be performed 30 minutes after the participant takes their medications but before putting on the compression garment. The participant will then put on the compression garment. The second (OVS #2) standing test will be performed 30 minutes after putting on the compression garment. The third (OVS #3) standing test will be performed a minimum of 3 hours after putting on the compression garment. After a minimum of 3hours, the participant will then remove the compression garment. The fourth standing test (OVS #4) will be performed 30 minutes after removing the garment. Participants will record their symptoms after each standing test, as well as medications taken each day in the provided study booklet.

Conditions

Postural Orthostatic Tachycardia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Waist-High Compression Tights and Medications

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.

Group Type: EXPERIMENTAL

Waist-High Compression Tights

Intervention Type: OTHER

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

Medications that modulate heart rate and blood pressure

Intervention Type: DRUG

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

Waist-High Compression Tights and No Medications

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.

Group Type: EXPERIMENTAL

Waist-High Compression Tights

Intervention Type: OTHER

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

Abdominal Compression Garments and Medications

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.

Group Type: EXPERIMENTAL

Abdominal Compression Garments

Intervention Type: OTHER

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

Medications that modulate heart rate and blood pressure

Intervention Type: 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 No Medications

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.

Group Type: EXPERIMENTAL

Abdominal Compression Garments

Intervention Type: OTHER

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

Interventions

Waist-High Compression Tights

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

Intervention Type: OTHER

Abdominal Compression Garments

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

Intervention Type: OTHER

Medications that modulate heart rate and blood pressure

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

Intervention Type: DRUG

Other Intervention Names

Abdominal shapewear, compression shorts

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Satish M Raj, MD MSCI

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kate M Bourne, BSc

Role: CONTACT

autonomic.research@ucalgary.ca

403-210-7401

Facility Contacts

Kate Bourne

Role: primary

403-210-7401

References

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.

Reference Type: DERIVED

PMID: 39614865 (View on PubMed)

Other Identifiers

REB20-2224

Identifier Type: -

Identifier Source: org_study_id