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

Primary Purpose

Postural Orthostatic Tachycardia Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Waist-High Compression Tights
Abdominal Compression Garments
Medications that modulate heart rate and blood pressure
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Waist-High Compression Tights and Medications

Waist-High Compression Tights and No Medications

Abdominal Compression Garments and Medications

Abdominal Compression Garments and No Medications

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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 .
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.
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.
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.

Full Information

First Posted
April 29, 2021
Last Updated
May 9, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT04881318
Brief Title
Compression Garments in the Community With POTS
Acronym
COM-COM-POTS
Official Title
Compression Garments in the Community With POTS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Orthostatic Tachycardia Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
It is not possible to mask participants to the compression garment intervention.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Waist-High Compression Tights and Medications
Arm Type
Experimental
Arm Description
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.
Arm Title
Waist-High Compression Tights and No Medications
Arm Type
Experimental
Arm Description
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.
Arm Title
Abdominal Compression Garments and Medications
Arm Type
Experimental
Arm Description
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.
Arm Title
Abdominal Compression Garments and No Medications
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Waist-High Compression Tights
Intervention Description
Waist-high compression tights providing 15-40 mmHg of pressure.
Intervention Type
Other
Intervention Name(s)
Abdominal Compression Garments
Other Intervention Name(s)
Abdominal shapewear, compression shorts
Intervention Description
Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.
Intervention Type
Drug
Intervention Name(s)
Medications that modulate heart rate and blood pressure
Intervention Description
Medications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants.
Primary Outcome Measure Information:
Title
WHC Heart Rate
Description
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.
Time Frame
10 minutes
Title
AC Heart Rate
Description
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.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Heart Rate - End of Study Day (WHC)
Description
Delta HR measurement from OVS #3 (with WHC) compared to the delta HR from the OVS #4 (without WHC).
Time Frame
10 minutes
Title
Heart Rate - WHC and Medication
Description
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 .
Time Frame
10 minutes
Title
Heart Rate - WHC and AC
Description
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.
Time Frame
10 minutes
Title
Heart Rate - End of Study Day (AC)
Description
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.
Time Frame
10 minutes
Title
Heart Rate - AC and Medication
Description
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.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kate M Bourne, BSc
Phone
403-210-7401
Email
autonomic.research@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish M Raj, MD MSCI
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kate Bourne
Phone
403-210-7401
First Name & Middle Initial & Last Name & Degree
Satish R. Raj, MD MSCI

12. IPD Sharing Statement

Plan to Share IPD
No

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Compression Garments in the Community With POTS

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