Compression Garments for POTS

(COM-COM-POTS Trial)

Overseen By Kate M Bourne, BSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Dehydration, Thyroid disease, Anxiety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Satish M Raj, MD MSCI

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults in Canada with a doctor's diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS) who can participate in a 4-day study and own waist-high compression tights. It excludes those with conditions that mimic POTS, severe anxiety, pregnancy, intolerance to compression garments, or non-ownership of the required garment.

Inclusion Criteria

I have been diagnosed with POTS by a doctor.

Resident of Canada

I can commit to a 4-day study with a break in between.

Exclusion Criteria

You will be excluded if you have severe anxiety or somatization symptoms.

Not a resident of Canada

You cannot wear tight clothing for the entire study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants will wear compression garments and undergo standing tests with and without medications

4 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Compression Garments

Trial Overview The trial tests if wearing commercially available waist-high and abdominal compression garments helps manage heart rate and symptoms in POTS patients outside the lab. Participants will use these garments during their daily activities over two segments separated by five days without them.

Participant Groups

Group I: Waist-High Compression Tights and No Medications Experimental Treatment 1 Intervention

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 II: Waist-High Compression Tights and Medications Experimental Treatment 2 Interventions

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 III: Abdominal Compression Garments and No Medications Experimental Treatment 1 Intervention

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 IV: Abdominal Compression Garments and Medications Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+