CClinicalTrials.gg
CompletedNCT03484273Updated Oct 22, 2021Results posted

Hemodynamic Effects of Compression in POTS

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

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Postural Tachycardia Syndrome

Keywords

  • Tilt Table
  • Compression
  • Dysautonomia
  • POTS
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Full Compression

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

    Device: LifeWrap Compression Garment

  • Experimental
    Abdominal and Pelvic Compression

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

    Device: LifeWrap Compression Garment

  • Experimental
    Lower Limb Compression

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

    Device: LifeWrap Compression Garment

  • No intervention
    No Compression

    None of the LifeWrap compression garment straps will be secured.

Interventions

  • DeviceLifeWrap Compression Garment

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

05

What researchers measure

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.

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

Secondary outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

06

Results

Posted May 12, 2021
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.

Participant flow

Participant flow — Overall Study
Milestone4 Compression Interventions in Randomized Order
Started32
Completed30
Not completed2
Withdrew: Equipment malfunction1
Withdrew: Data excluded from analysis1

Outcome measures

PrimaryOrthostatic 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
Reported as:
Mean · beats per minute
Orthostatic Heart Rate (HR) Change
beats per minuteFull CompressionAbdominal and Pelvic CompressionLower Limb CompressionNo Compression
Orthostatic Heart Rate (HR) Change23 ± 1128 ± 1134 ± 1439 ± 18
Statistical analysis
  • Full Compression vs Abdominal and Pelvic Compression vs Lower Limb Compression vs No Compression · ANOVA · p = <0.001Repeated Measures ANOVA
SecondaryMaximum 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
Reported as:
Mean · beats per minute (bpm)
Maximum Upright Heart Rate
beats per minute (bpm)Full CompressionAbdominal and Pelvic CompressionLower Limb CompressionNo Compression
Maximum Upright Heart Rate92 ± 1497 ± 15103 ± 16109 ± 19
Statistical analysis
  • Full Compression vs Abdominal and Pelvic Compression vs Lower Limb Compression vs No Compression · Repeated Measures ANOVA · p = <0.001
SecondaryDifferences 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)
Reported as:
Mean · units on a scale
Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating
units on a scaleFull CompressionAbdominal and Pelvic CompressionLower Limb CompressionNo Compression
Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating12 ± 1015 ± 1222 ± 1726 ± 17
Statistical analysis
  • Full Compression vs Abdominal and Pelvic Compression vs Lower Limb Compression vs No Compression · Repeated Measures ANOVA · p = <0.001
SecondaryChange 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.
Reported as:
Mean · mmHg
Change in Systolic Blood Pressure (SBP)
mmHgFull CompressionAbdominal and Pelvic CompressionLower Limb CompressionNo Compression
Change in Systolic Blood Pressure (SBP)-5 ± 7-7 ± 8-10 ± 10-10 ± 10
Statistical analysis
  • Full Compression vs Abdominal and Pelvic Compression vs Lower Limb Compression vs No Compression · Repeated Measures ANOVA · p = 0.01
SecondaryChanges 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.
Reported as:
Mean · mL
Changes in Stroke Volume
mLFull CompressionAbdominal and Pelvic CompressionLower Limb CompressionNo Compression
Changes in Stroke Volume-22 ± 12-22 ± 12-33 ± 14-34 ± 11
Statistical analysis
  • Full Compression vs Abdominal and Pelvic Compression vs Lower Limb Compression vs No Compression · Repeated Measures ANOVA · p = <0.001
SecondaryChange 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.
Reported as:
Mean · L/min
Change in Cardiac Output (CO)
L/minFull CompressionAbdominal and Pelvic CompressionLower Limb CompressionNo Compression
Change in Cardiac Output (CO)0.1 ± 0.70.3 ± 0.7-0.2 ± 1-0.2 ± 0.8
Statistical analysis
  • Full Compression vs Abdominal and Pelvic Compression vs Lower Limb Compression vs No Compression · Repeated Measures ANOVA · p = 0.001
SecondaryChange 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.
Reported as:
Mean · dyne*s/cm^5
Change in Systemic Vascular Resistance (SVR)
dyne*s/cm^5Full CompressionAbdominal and Pelvic CompressionLower Limb CompressionNo Compression
Change in Systemic Vascular Resistance (SVR)-31 ± 132-63 ± 152-22 ± 1574.7 ± 145
Statistical analysis
  • Full Compression vs Abdominal and Pelvic Compression vs Lower Limb Compression vs No Compression · Repeated Measures ANOVA · p = 0.04
SecondaryChange 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.

Results for this outcome have not been posted.

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
Full Compression0/32 (0%)0/32 (0%)0/32 (0%)
Abdominal and Pelvic Compression0/32 (0%)0/32 (0%)0/32 (0%)
Lower Limb Compression0/32 (0%)0/32 (0%)0/32 (0%)
No Compression0/32 (0%)0/32 (0%)0/32 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Full Compression
Mean32 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Full Compression
Female28
Male2
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Full Compression
Region of Enrollment
Region of Enrollment(Participants)Full Compression
Canada30
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Full Compression
Mean24 ± 6
07

Study locations

1 site
  • Unversity of Calgary
    Calgary, Alberta, Canada
08

References and documents

Publications

  • 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. PubMed 33478652 ↗

Study documents

  • Protocol and statistical analysis plan · Jan 26, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03484273
Lead sponsor
University of Calgary
Responsible party
Dr. Satish Raj (Professor; Medical Director, Calgary Autonomic Investigation & Management Clinic, University of Calgary) — Principal investigator
First posted
Mar 30, 2018
Start date
Jul 12, 2018
Primary completion
Apr 1, 2020
Completion
Jan 26, 2021
Results posted
May 12, 2021
Last update
Oct 22, 2021

Study contacts

Satish R Raj, MD, MSCI
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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