Compression Garments in the Community With POTS (COM-COM-POTS)

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.

Study Overview

• Status: Recruiting
• Conditions: Postural Orthostatic Tachycardia Syndrome
• Intervention / Treatment: Other: Waist-High Compression Tights; Drug: Medications that modulate heart rate and blood pressure; Other: Abdominal Compression Garments

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate M Bourne, BSc; Phone Number: 403-210-7401; Email: autonomic.research@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Recruiting
      • University of Calgary
      • Contact: Kate Bourne; Phone Number: 403-210-7401
      • Principal Investigator: Satish R. Raj, MD MSCI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Waist-High Compression Tights; Waist-high compression tights providing 15-40 mmHg of pressure.; Drug: 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.
Experimental: 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.	Other: Waist-High Compression Tights; Waist-high compression tights providing 15-40 mmHg of pressure.
Experimental: 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.	Drug: 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.; Other: Abdominal Compression Garments; Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.; Other Names: Abdominal shapewear, compression shorts
Experimental: 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.	Other: Abdominal Compression Garments; Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.; Other Names: Abdominal shapewear, compression shorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate - End of Study Day (WHC)	Delta HR measurement from OVS #3 (with WHC) compared to the delta HR from the OVS #4 (without WHC).	10 minutes
Heart Rate - WHC and Medication	The delta HR from OVS #1 - OVS #2 in the "With Medication" phase, compared to the delta HR from OVS #1 - OVS #2 in the "Without Medication" phase .	10 minutes
Heart Rate - WHC and AC	Delta HR from OVS #1 - OVS #2 on the WHC day, compared to OVS #1 - OVS #2 on the AC day, in the "With Medication" phase. This will provide an assessment of the differential efficacy of commercial WHC versus commercial AC in a home setting.	10 minutes
Heart Rate - End of Study Day (AC)	Delta HR measurement from OVS #3 (with AC) compared to the delta HR from the OVS #4 (without AC). This will provide an assessment of the efficacy of commercial AC with prolonged use during the day.	10 minutes
Heart Rate - AC and Medication	The delta HR from OVS #1 - OVS #2 in the "With Medication" phase, compared to the delta HR from OVS #1 - OVS #2 in the "Without Medication" phase. This will provide an assessment of the differential efficacy of commercial AC with and without POTS medications.	10 minutes

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Satish M Raj, MD MSCI, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: REB20-2224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No