Postural Orthostatic Tachycardia SyndromeCOM-COM-POTSNCT04881318
Compression Garments in the Community With POTS
A study testing Waist-High Compression Tights, Abdominal Compression Garments and Medications that modulate heart rate and blood pressure in people with Postural Orthostatic Tachycardia Syndrome, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- Waist-High Compression Tights, Abdominal Compression Garments and Medications that modulate heart rate and blood pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 17 May 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 4Z6
Kate Bourne, 403-210-7401
Satish R. Raj, MD MSCI
About this study
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.
Read the 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.
- Being tested
- Waist-High Compression Tights, Abdominal Compression Garments, Medications that modulate heart rate and blood pressure
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waist-High Compression TightsOther
Also called Full Length Compression Tights
Waist-high compression tights providing 15-40 mmHg of pressure.
Abdominal Compression GarmentsOther
Also called Abdominal shapewear, compression shorts
Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.
Medications that modulate heart rate and blood pressureDrug
Medications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Abdominal Compression Garments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minutes
Secondary outcomes (5)
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).
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start17 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postural Orthostatic Tachycardia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satish M Raj, MD MSCI, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881318
- Sponsor's protocol ID
- REB20-2224
- Acronym
- COM-COM-POTS
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Jun;42(6):1320-1328. doi: 10.1016/j.cjca.2025.11.038. Epub 2025 Dec 1.
PubMed 41338488Bourne 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.
PubMed 39614865
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compression Garments in the Community With POTS
- ClinicalTrials.gov ID
- NCT04881318
- Acronym / sponsor ID
- COM-COM-POTS / REB20-2224
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Waist-High Compression Tights and Medications | Experimental | Other: Waist-High Compression Tights, Drug: Medications that modulate heart rate and blood pressureParticipants 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. |
| Waist-High Compression Tights and No Medications | Experimental | Other: Waist-High Compression TightsParticipants 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. |
| Abdominal Compression Garments and Medications | Experimental | Other: Abdominal Compression Garments, Drug: Medications that modulate heart rate and blood pressureParticipants 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. |
| Abdominal Compression Garments and No Medications | Experimental | Other: Abdominal Compression GarmentsParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Waist-High Compression TightsAlso: Full Length Compression TightsWaist-high compression tights providing 15-40 mmHg of pressure. | Other | Waist-High Compression Tights and Medications, Waist-High Compression Tights and No Medications |
| Abdominal Compression GarmentsAlso: Abdominal shapewear, compression shortsAbdominal compression garment compressing the abdomen, buttocks, and upper thighs. | Other | Abdominal Compression Garments and Medications, Abdominal Compression Garments and No Medications |
| Medications that modulate heart rate and blood pressureMedications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants. | Drug | Abdominal Compression Garments and Medications, Waist-High Compression Tights and Medications |
Primary outcome
WHC Heart Rate
Time frame: 10 minutes
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
Time frame: 10 minutes
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.
5 secondary outcomes
Heart Rate - End of Study Day (WHC)
Time frame: 10 minutes
Heart Rate - WHC and Medication
Time frame: 10 minutes
Heart Rate - WHC and AC
Time frame: 10 minutes
Heart Rate - End of Study Day (AC)
Time frame: 10 minutes
Heart Rate - AC and Medication
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 41338488Bourne 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. 2026 Jun;42(6):1320-1328. doi: 10.1016/j.cjca.2025.11.038. Epub 2025 Dec 1.
- Derived from this study: PubMed 39614865Bourne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Satish M Raj, MD MSCI principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waist-High Compression Tights, Abdominal Compression Garments and Medications that modulate heart rate and blood pressure in people with Postural Orthostatic Tachycardia Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate M Bourne, BSc (403-210-7401, autonomic.research@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHC Heart Rate (time frame: 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.