Hemodynamic Effects of Compression in POTS

NCT03484273 | Completed Results

• 1 other identifier: REB17-2393
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Postural Tachycardia Syndrome

Keywords

Tilt Table; Compression; Dysautonomia; POTS

Outcome Measures

Primary Outcomes (1)

• Orthostatic Heart Rate (HR) Change

  The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.

  Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR

Secondary Outcomes (7)

• Maximum Upright Heart Rate

  During minutes 5-10 of the HUT

• Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating

  After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)

• Change in Systolic Blood Pressure (SBP)

  During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

• Changes in Stroke Volume

  During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

• Change in Cardiac Output (CO)

  During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Study Arms (4)

Full Compression

EXPERIMENTAL

The LifeWrap compression garment will be fully secured with all straps.

Device: LifeWrap Compression Garment

Abdominal and Pelvic Compression

EXPERIMENTAL

The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.

Device: LifeWrap Compression Garment

Lower Limb Compression

EXPERIMENTAL

The Lifewrap compression garment calf and ankle straps only will be secured.

Device: LifeWrap Compression Garment

No Compression

NO INTERVENTION

None of the LifeWrap compression garment straps will be secured.

Interventions

LifeWrap Compression Garment DEVICE

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

Abdominal and Pelvic Compression; Full Compression; Lower Limb Compression

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Physician diagnosis of Postural Tachycardia Syndrome (POTS)
• Age 18-60 years (we are an adult group and we do not see pediatric patients clinically and do not have appropriate pediatric expertise)
• Male and Female
• Able and willing to provide informed consent
• Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB.

You may not qualify if:

• Overt cause for postural tachycardia, i.e., acute dehydration
• Participants with somatization or severe anxiety symptoms will be excluded (as they may not tolerated study procedures)
• Pregnant women
• Inability to tolerate compression garment for the duration of the study
• Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Unversity of Calgary

Calgary, Alberta, Canada

Location

Related Publications (1)

• Bourne KM, Sheldon RS, Hall J, Lloyd M, Kogut K, Sheikh N, Jorge J, Ng J, Exner DV, Tyberg JV, Raj SR. Compression Garment Reduces Orthostatic Tachycardia and Symptoms in Patients With Postural Orthostatic Tachycardia Syndrome. J Am Coll Cardiol. 2021 Jan 26;77(3):285-296. doi: 10.1016/j.jacc.2020.11.040.

  PMID: 33478652 DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Autonomic Nervous System Diseases

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Nervous System Diseases

Limitations and Caveats

This was a proof of principle study. The garment used is not one that a typical patient would use in their day to day lives. The use of "real-world" garments requires further testing.

Results Point of Contact

• Title: Dr. Satish R. Raj
• Organization: University of Calgary

satish.raj@ucalgary.ca

403-210-6152

Study Officials

• Satish R Raj, MD, MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Medical Director, Calgary Autonomic Investigation & Management Clinic

Model Details: There will be 4 compression conditions based on strap configuration of the Lifewrap garment: full abdominal and lower extremity compression, abdominal only compression, lower extremity only compression and no compression. The order of these interventions will be randomized.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 30, 2018
• Study Start: July 12, 2018
• Primary Completion: April 1, 2020
• Study Completion: January 26, 2021
• Last Updated: October 22, 2021
• Results First Posted: May 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)