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Hemodynamic Effects of Compression in POTS

NCT03484273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-10-22

Study results available
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Summary

When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate increases significantly (\>30BPM) and they may experience symptoms such as lightheadedness, dizziness, shortness of breath, nausea and mental confusion.

One commonly prescribed treatment for POTS is compression garments. Compression garments squeeze veins to help return blood back to the heart, which may decrease heart rate and symptoms on standing. However, there is little research about the effectiveness of compression in adults with POTS.

In this study, the investigators will use the Lifewrap garment, which compresses the abdomen, pelvis and lower extremities, to evaluate the effectiveness of compression in POTS. The investigators will use a head up tilt (HUT) which will simulate standing. The study participant will participate in 4x 10 minute HUTs wearing 4 different compression configurations:

1. full abdomen and lower extremity compression
2. abdominal only compression
3. leg only compression
4. No compression

The investigators hypothesize that with full compression, the participant's heart rate increase from lying down to upright will be lower than when they are not wearing any compression. The investigators will also ask the participant about their symptoms when they are upright.

The results of this study could demonstrate the potential benefits of compression and what configuration is most effective. These findings could rapidly translate to the clinical setting, providing improved care.

Conditions

  • Postural Tachycardia Syndrome

Interventions

DEVICE

LifeWrap Compression Garment

Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Principal Investigators

  • Satish R Raj, MD, MSCI · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2020-04-01
Completion
2021-01-26

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03484273 on ClinicalTrials.gov