Compression Garments in the Community With POTS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Calgary
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Waist-High Compression Tights
Other interventionWaist-high compression tights providing 15-40 mmHg of pressure.
Abdominal Compression Garments
Other interventionAbdominal compression garment compressing the abdomen, buttocks, and upper thighs.
Medications that modulate heart rate and blood pressure
DrugMedications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants.
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: Waist-High Compression Tights and MedicationsExperimental treatment 2 interventions
Group B: Waist-High Compression Tights and No MedicationsExperimental treatment 1 intervention
Group C: Abdominal Compression Garments and MedicationsExperimental treatment 2 interventions
Group D: Abdominal Compression Garments and No MedicationsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 minutes2
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.
Time frame
10 minutesSecondary outcomes
1
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).
Time frame
10 minutes2
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 .
Time frame
10 minutes3
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.
Time frame
10 minutes4
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.
Time frame
10 minutesSponsors and contacts
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Source ClinicalTrials.gov