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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04881318
Other study ID # REB20-2224
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 17, 2021
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University of Calgary
Contact Kate M Bourne, BSc
Phone 403-210-7401
Email autonomic.research@ucalgary.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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Study Design


Related Conditions & MeSH terms

  • Postural Orthostatic Tachycardia Syndrome
  • Tachycardia

Intervention

Other:
Waist-High Compression Tights
Waist-high compression tights providing 15-40 mmHg of pressure.
Abdominal Compression Garments
Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.
Drug:
Medications that modulate heart rate and blood pressure
Medications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants.

Locations

Country Name City State
Canada University of Calgary Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 10 minutes
Primary 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. 10 minutes
Secondary 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). 10 minutes
Secondary 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 . 10 minutes
Secondary 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. 10 minutes
Secondary 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. 10 minutes
Secondary 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. 10 minutes
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