NCT03484273

Hemodynamic Effects of Compression in POTS

Completed NA Results posted Last updated 22 October 2021

What this trial tests

NA trial testing LifeWrap Compression Garment in Postural Tachycardia Syndrome in 32 participants. Completed in 26 January 2021.

Timeline

12 July 2018

Primary endpoint
1 April 2020

26 January 2021

Quick facts

Lead sponsor	University of Calgary
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	12 July 2018
Primary completion	1 April 2020
Estimated completion	26 January 2021
Sites	1 location across Canada

Drugs / interventions tested

• LifeWrap Compression Garment

Conditions studied

• Postural Tachycardia Syndrome — all drugs for Postural Tachycardia Syndrome →

Sponsor

University of Calgary

Who can join

Adults 18 to 60, any sex, with Postural Tachycardia Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Orthostatic Heart Rate (HR) Change Primary · Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR

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.

Group	Value	95% CI
Full Compression	23	± 11
Abdominal and Pelvic Compression	28	± 11
Lower Limb Compression	34	± 14
No Compression	39	± 18

Maximum Upright Heart Rate Secondary · During minutes 5-10 of the HUT

The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.

Group	Value	95% CI
Full Compression	92	± 14
Abdominal and Pelvic Compression	97	± 15
Lower Limb Compression	103	± 16
No Compression	109	± 19

Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating Secondary · After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)

Subjective symptom scoring as reported by participant during each study arm. The VOSS evaluates 9 symptoms on a 0 to 10 scale with 0 being no symptom to 10 being worst ever symptom. The total score ranges from 0-90, with a higher score being more severe symptoms. The 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. The participant's VOSS score will be compared across the 4 arms of this study. The VOSS score has been previously used in multiple publications

Group	Value	95% CI
Full Compression	12	± 10
Abdominal and Pelvic Compression	15	± 12
Lower Limb Compression	22	± 17
No Compression	26	± 17

Change in Systolic Blood Pressure (SBP) Secondary · During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Change in continuous systolic blood pressure between supine and HUT during each study arm.

Group	Value	95% CI
Full Compression	-5	± 7
Abdominal and Pelvic Compression	-7	± 8
Lower Limb Compression	-10	± 10
No Compression	-10	± 10

Changes in Stroke Volume Secondary · 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 Stroke Volume from supine to HUT in each of the study arms.

Group	Value	95% CI
Full Compression	-22	± 12
Abdominal and Pelvic Compression	-22	± 12
Lower Limb Compression	-33	± 14
No Compression	-34	± 11

Change in Cardiac Output (CO) Secondary · During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.

Change in Cardiac Output from supine to HUT in each of the study arms.

Group	Value	95% CI
Full Compression	0.1	± 0.7
Abdominal and Pelvic Compression	0.3	± 0.7
Lower Limb Compression	-0.2	± 1
No Compression	-0.2	± 0.8

Change in Systemic Vascular Resistance (SVR) Secondary · During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.

Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.

Group	Value	95% CI
Full Compression	-31	± 132
Abdominal and Pelvic Compression	-63	± 152
Lower Limb Compression	-22	± 157
No Compression	4.7	± 145

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Compression Garment Reduces Orthostatic Tachycardia and Symptoms in Patients With Postural Orthostatic Tachycardia Syndrome.
   Bourne KM, Sheldon RS, Hall J, Lloyd M, et al · · 2021 · cited 43× · PMID 33478652 · DOI 10.1016/j.jacc.2020.11.040