N/A
N=32
Hemodynamic Effects of Compression in POTS
Postural Tachycardia Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03484273 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Orthostatic Heart Rate (HR) Change — 23; 28; 34; 39 beats per minute — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LifeWrap Compression Garment (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Calgary
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Orthostatic Heart Rate (HR) Change |
23; 28; 34; 39 | <0.001 sig |
| SECONDARY Maximum Upright Heart Rate |
92; 97; 103; 109 | <0.001 sig |
| SECONDARY Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating |
12; 15; 22; 26 | <0.001 sig |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
-5; -7; -10; -10 | 0.01 sig |
| SECONDARY Changes in Stroke Volume |
-22; -22; -33; -34 | <0.001 sig |
| SECONDARY Change in Cardiac Output (CO) |
0.1; 0.3; -0.2; -0.2 | 0.001 sig |
| SECONDARY Change in Systemic Vascular Resistance (SVR) |
-31; -63; -22; 4.7 | 0.04 sig |
| SECONDARY Change in Cerebral Blood Flow Velocity (CBFV) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03484273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.