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Postural Tachycardia SyndromeNCT03484273

Hemodynamic Effects of Compression in POTS

A study testing LifeWrap Compression Garment in people with Postural Tachycardia Syndrome, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Postural Tachycardia Syndrome
What is being tested?
LifeWrap Compression Garment
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteCanada
Study dates
12 Jul 2018to 26 Jan 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Unversity of Calgary

    Calgary, Alberta

Other trials in Canada

About this study

Official title: Body Compression in Postural Tachycardia Syndrome (POTS): Effects on Orthostatic Tolerance

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.

Read more

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.

Being tested
LifeWrap Compression Garment
Keywords
Tilt Table, Compression, Dysautonomia, POTS
Medical subject headings
Postural Orthostatic Tachycardia Syndrome, Autonomic Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LifeWrap Compression GarmentDevice

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

Study groups in NCT03484273
Study groupRoleWhat they receive
Full CompressionExperimentalThe LifeWrap compression garment will be fully secured with all straps.
Receives: Device: LifeWrap Compression Garment
Abdominal and Pelvic CompressionExperimentalThe Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured.
Receives: Device: LifeWrap Compression Garment
Lower Limb CompressionExperimentalThe Lifewrap compression garment calf and ankle straps only will be secured.
Receives: Device: LifeWrap Compression Garment
No CompressionNo interventionNone of the LifeWrap compression garment straps will be secured.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start12 Jul 2018
  3. Primary completion1 Apr 2020
  4. Study completion26 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03484273
Sponsor's protocol ID
REB17-2393
Status last verified
Sep 2021
First submitted
19 Mar 2018
Last updated
22 Oct 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing LifeWrap Compression Garment in people with Postural Tachycardia Syndrome, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Orthostatic Heart Rate (HR) Change (time frame: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03484273, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

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