An interventional study of LifeWrap Compression Garment in Postural Tachycardia Syndrome, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
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Among 12 studies in Postural Orthostatic Tachycardia Syndrome with a site in Canada — 8 open to participants now, 8 under way, none of them phase 3. Postural Orthostatic Tachycardia Syndrome · Canada.
Among the 12 studies in Postural Orthostatic Tachycardia Syndrome with a site in Canada, this one is the 6th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2018, is one of 8 with no phase, and was the 2nd registered.
136 studies on the registry are indexed under Postural Orthostatic Tachycardia Syndrome; 42 are open to participants now.
Browse Postural Orthostatic Tachycardia Syndrome studies →8 of the 12 studies in Postural Orthostatic Tachycardia Syndrome with a site in Canada are open now. Recruiting first, the newest first:
University of Calgary · Sites in Canada
Ages 18–60 · Healthy volunteers
University of Calgary · Sites in Canada
Ages 18–60
Simon Fraser University · Sites in Canada
Ages 6–18
Dr. Victoria Claydon · Sites in Canada
Ages 6–18
University of Calgary · Sites in Canada
Ages 18–60
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 29 Postural Orthostatic Tachycardia Syndrome studies recruiting now, 9 (31%) set no upper age limit and 16 (55%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 32 is below the median of 36 across 102 interventional studies indexed under Postural Orthostatic Tachycardia Syndrome.
Median enrollment 32 across the 11 interventional studies, 125 across the 1 observational. Of the 3 that completed or were terminated, 2 (67%) have results posted.
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2 of 12 have an industry lead sponsor. The 5 most frequent:
University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
University of Calgary has 9 studies filed under Postural Orthostatic Tachycardia Syndrome — fewer than ten, so there is no comparison to draw.
3 of the studies in Postural Orthostatic Tachycardia Syndrome with a site in Canada that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04881318University of CalgaryCompression Garments in the Community With POTS | 2026-12-31 |
| NCT05633693Simon Fraser UniversityPostural Sway and Counterpressure Maneuvers for Pediatric Syncope | 2027-05 |
| NCT05555771Dr. Victoria ClaydonPaediatric Syncope in the Emergency Department | 2027-09-30 |
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Among the 12 studies in Postural Orthostatic Tachycardia Syndrome with a site in Canada, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
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.
Postural Tachycardia Syndrome (POTS) is a chronic form of orthostatic intolerance marked by a significant and sustained increase in heart rate (HR) upon positional change from supine to standing (>30 beats/min [bpm]) in the absence of orthostatic hypotension (\<20/10 mmHg decrease). Symptoms must be present for >6 months and other causes of orthostatic tachycardia must be ruled out. Individuals with POTS report orthostatic symptoms including palpitations, lightheadedness, and mental clouding, which improve on recumbence. The vast majority of individuals diagnosed with POTS are women age 13-50 years.
Upon standing, approximately 500 mL of blood immediately redistributes from the thorax down to the abdomen, buttocks and legs. This leads to sympathetic activation as the baroreceptors sense less pressure. In a healthy individual, HR initially increases 10-20 bpm, and the systolic blood pressure (BP) decreases by approximately 5 mmHg. However, in an individual with POTS, this compensatory mechanism is impaired and HR will increase by >30 bpm and remain at this elevated rate for the duration of standing. In some individuals with POTS, upon standing cerebral blood flow velocity decreases. In other individuals, oscillation of cerebral blood flow due to failure of cerebral autoregulatory mechanisms is observed.
Current treatment of POTS involves pharmacological and non-pharmacological intervention including salt and fluid loading, exercise, and physical countermanuevers. There are no approved medications for use in POTS and all use is off label. Compression garments are also often prescribed. Abdominal/lower extremity compression garments provide pressure to the blood vessels in the legs, thighs and abdomen which can minimize blood pooling and lead to improved blood return to the heart. One such garment is the Lifewrap Non-pneumatic AntiShock garment (NASG), indicated in post-partum hypovolemia.
A pediatric study (n=20) found that orthostatic tachycardia and symptoms were decreased during head up tilt (HUT), with the use of a different NASG compression garment vs. no compression. However, there is no data to validate the efficacy of compression in adults POTS, and also no data to determine which type of compression is most beneficial (e.g. lower leg only, abdomen only, combination).
The investigators hypothesize that the use of the Lifewrap NASG compression garment in a fully applied configuration will decrease orthostatic tachycardia and orthostatic symptoms during a 10 minute HUT vs. no compression garment. The investigators will complete a 4-way randomized crossover study of HUTs with compression applied by the LifeWrap NSAG in at attempt to demonstrate decreased orthostatic tachycardia and increased orthostatic tolerance in individuals with POTS. If successful, this study could provide needed evidence that compression in POTS is a successful non-pharmacological treatment modality, and as well, what type of compression is the most beneficial to patients with this syndrome. These findings could rapidly translate to the clinical setting and improve patient care.
The study participant will complete 4x 10min HUTs during a single study day. There will be 4 compression conditions based on strap configuration of the Lifewrap garment: (1) full abdominal and lower extremity compression, (2) abdominal only compression, (3) lower extremity only compression and (4) no compression. A pressure sensor will used to measure the magnitude of compression pressure applied. The study will be conducted on a tilt table in a human physiology research and procedure room. Each intervention phase in the protocol will involve a supine baseline assessment period of 10 minutes followed by a 10 min HUT (80 degrees). There will be a 20 min recovery periods between each HUT. The study will take approximately 4 hours.
The study participant will be instrumented in a fasting state and on an empty bladder. The investigators will apply skin electrodes to continuously monitor heart rate and record an ECG. BP will be monitored continuously using a finger volume clamp method (Nexfin, Edwards Lifesciences) and calibrated with intermittent brachial cuff measurements (Vital-Guard 450C Patient Care Monitor, IVY Medical). From the continuous BP waveform, the investigators can obtain an estimate of stroke volume, cardiac output, and systemic vascular resistance (Modelflow). Middle cerebral blood flow velocity will be assessed using transcranial doppler.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The LifeWrap compression garment will be fully secured with all straps.
Device: LifeWrap Compression Garment
The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.
Device: LifeWrap Compression Garment
The Lifewrap compression garment calf and ankle straps only will be secured.
Device: LifeWrap Compression Garment
None of the LifeWrap compression garment straps will be secured.
Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.
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.
Time frame: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR
Maximum Upright Heart Rate
The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.
Time frame: During minutes 5-10 of the HUT
Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating
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
Time frame: 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)
Change in continuous systolic blood pressure between supine and HUT during each study arm.
Time frame: 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
Change in Stroke Volume from supine to HUT in each of the study arms.
Time frame: 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)
Change in Cardiac Output from supine to HUT in each of the study arms.
Time frame: 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 Systemic Vascular Resistance (SVR)
Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.
Time frame: During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.
Change in Cerebral Blood Flow Velocity (CBFV)
Change in cerebral blood flow from supine to HUT in each of the study arms.
Time frame: During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
| Milestone | 4 Compression Interventions in Randomized Order |
|---|---|
| Started | 32 |
| Completed | 30 |
| Not completed | 2 |
| Withdrew: Equipment malfunction | 1 |
| Withdrew: Data excluded from analysis | 1 |
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.
| beats per minute | Full Compression | Abdominal and Pelvic Compression | Lower Limb Compression | No Compression |
|---|---|---|---|---|
| Orthostatic Heart Rate (HR) Change | 23 ± 11 | 28 ± 11 | 34 ± 14 | 39 ± 18 |
The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.
| beats per minute (bpm) | Full Compression | Abdominal and Pelvic Compression | Lower Limb Compression | No Compression |
|---|---|---|---|---|
| Maximum Upright Heart Rate | 92 ± 14 | 97 ± 15 | 103 ± 16 | 109 ± 19 |
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
| units on a scale | Full Compression | Abdominal and Pelvic Compression | Lower Limb Compression | No Compression |
|---|---|---|---|---|
| Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating | 12 ± 10 | 15 ± 12 | 22 ± 17 | 26 ± 17 |
Change in continuous systolic blood pressure between supine and HUT during each study arm.
| mmHg | Full Compression | Abdominal and Pelvic Compression | Lower Limb Compression | No Compression |
|---|---|---|---|---|
| Change in Systolic Blood Pressure (SBP) | -5 ± 7 | -7 ± 8 | -10 ± 10 | -10 ± 10 |
Change in Stroke Volume from supine to HUT in each of the study arms.
| mL | Full Compression | Abdominal and Pelvic Compression | Lower Limb Compression | No Compression |
|---|---|---|---|---|
| Changes in Stroke Volume | -22 ± 12 | -22 ± 12 | -33 ± 14 | -34 ± 11 |
Change in Cardiac Output from supine to HUT in each of the study arms.
| L/min | Full Compression | Abdominal and Pelvic Compression | Lower Limb Compression | No Compression |
|---|---|---|---|---|
| Change in Cardiac Output (CO) | 0.1 ± 0.7 | 0.3 ± 0.7 | -0.2 ± 1 | -0.2 ± 0.8 |
Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.
| dyne*s/cm^5 | Full Compression | Abdominal and Pelvic Compression | Lower Limb Compression | No Compression |
|---|---|---|---|---|
| Change in Systemic Vascular Resistance (SVR) | -31 ± 132 | -63 ± 152 | -22 ± 157 | 4.7 ± 145 |
Change in cerebral blood flow from supine to HUT in each of the study arms.
Results for this outcome have not been posted.
Collected over This was a half day study and there was no ongoing follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Full Compression | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Abdominal and Pelvic Compression | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Lower Limb Compression | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| No Compression | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | Full Compression |
|---|---|
| Mean | 32 ± 11 |
| Sex: Female, Male(Participants) | Full Compression |
|---|---|
| Female | 28 |
| Male | 2 |
| Race and Ethnicity Not Collected(Participants) | Full Compression |
|---|
| Region of Enrollment(Participants) | Full Compression |
|---|---|
| Canada | 30 |
| Body Mass Index (BMI)(kg/m^2) | Full Compression |
|---|---|
| Mean | 24 ± 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in Apr 2020, 20 months.
Results were first posted in May 2021, 1 year 1 month after primary completion.
Of 44 non-industry interventional studies with no phase under Postural Orthostatic Tachycardia Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 61. This study's 20 months is below that.
Counting every sponsor, half of 44 studies reached it within 46 months; a quarter within 20 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Postural Orthostatic Tachycardia Syndrome →