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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether compression garments can improve symptoms and heart rate in individuals with Postural Orthostatic Tachycardia Syndrome (POTS). Participants will test various compression garments, such as waist-high tights and abdominal shapewear, both with and without their regular medications. The trial is open to Canadian residents diagnosed with POTS by a doctor who already own compression tights. It suits those able to commit to a 4-day participation window. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance daily life for those with POTS.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

What prior data suggests that these compression garments are safe for POTS patients?

Research shows that compression garments are generally safe for people with POTS (Postural Orthostatic Tachycardia Syndrome). Studies have found that patients often use both stomach and full-length compression garments, and they are well-tolerated. In one study, 63% of participants used these garments without major problems. These garments help lower rapid heart rate and improve POTS symptoms, especially when combined with certain medications like beta-blockers.

While some individuals might feel slight discomfort wearing them, serious side effects are rare. Communities have widely used these garments, and no major safety issues have been reported. Those considering joining a trial or using compression garments should consult a healthcare provider to ensure suitability for their health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using compression garments for treating Postural Orthostatic Tachycardia Syndrome (POTS) because these garments offer a drug-free way to manage symptoms. Unlike standard treatments for POTS, which often include medications like beta-blockers and ivabradine to control heart rate and blood pressure, compression garments provide support through physical pressure. This method improves blood flow and reduces dizziness without the potential side effects of medication. The trial is examining different types of compression garments—abdominal and waist-high—both with and without concurrent medication use, to see how they can best help people with POTS. This approach could lead to more versatile and personalized management options for patients.

What evidence suggests that this trial's compression garments could be effective for POTS?

This trial will evaluate the effectiveness of different compression garments for people with POTS. Research has shown that abdominal compression garments can help lower heart rates and improve symptoms. One study found these garments work especially well when combined with beta-blockers, a type of medicine that helps control heart rate. In this trial, some participants will wear abdominal compression garments with their regular medications, while others will wear them without medications. Similarly, waist-high compression tights have also shown promise. Studies in everyday settings suggest they can help reduce heart rates and ease symptoms for those with POTS. Participants in this trial will also be divided into groups wearing waist-high compression tights with or without medications. Both types of compression garments provide useful support for managing this condition. ^{1 3 4 5 6}

Who Is on the Research Team?

Satish M Raj, MD MSCI

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33478652/

Compression Garment Reduces Orthostatic Tachycardia ... Conclusions: Abdominal and lower body compression reduced heart rate and improved symptoms during HUT in adult patients with POTS. These effects ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2020.11.040

Compression Garment Reduces Orthostatic Tachycardia ... This study investigated the effectiveness of body compression to reduce orthostatic tachycardia and improve orthostatic symptoms in adults diagnosed with POTS.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405500X24008600

A Community-Based Trial of Commercially Available ... This study tested the ability of commercially available WHC garments to reduce heart rate and improve symptoms in patients with POTS in a community setting.

4. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.017610

Abdominal Compression as a Treatment for Postural ... This study provides evidence that abdominal compression may be an effective treatment for POTS, especially when used in combination with a β‐blocker.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04881318

Compression Garments in the Community With POTS A recent proof-of-concept compression garment study performed by our research lab demonstrated significant HR and symptom reductions with compression, with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11583883/

An Exploration of Compression Garment Use in Patients ... All participants were aware of compression garments as a POTS treatment. In the year before the survey, 63% (n = 17) used a compression garment for POTS (Table ...