Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients

This study is currently recruiting participants.
Verified February 2013 by Nationwide Children's Hospital
Sponsor:
Information provided by (Responsible Party):
Geoffrey Heyer, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01795469
First received: February 18, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in adolescent patients. The aims of our study are to compare heart-rate changes and symptom onset during tilt table testing (a) with and without abdomen/lower extremity compression and (b) with abdominal compression only versus lower extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full compression (trial #2), and a third study without compression up to 10 minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression only [n=10] or lower extremity compression only [n=10] (trial #2), and a third study repeated without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare mean heart rates between trials for each study phase. Hazard analyses will be used to assess time-based endpoints.


Condition Intervention
Postural Orthostatic Tachycardia Syndrome (POTS)
Syncope
Device: Zoex compression garment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Heart-rate elevation [ Time Frame: Comparison between tilt table trials of up to 10 minutes duration without and with abdominal and/or lower extremity compression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom onset [ Time Frame: Comparison between tilt table trials of up to 10 minutes duration witout and with abdominal and/or lower extremity compression ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abdominal and lower extremity compression
Zoex compression garment during tilt testing (all straps)
Device: Zoex compression garment
5-strap compression of abdomen, thighs and legs
Experimental: abdominal compression only
Zoex compression garment use during tilt table testing (straps 4 and 5 fastened around thighs and abdomen)
Device: Zoex compression garment
5-strap compression of abdomen, thighs and legs
Experimental: Lower extremity compression only
Zoex compression garment use during tilt table testing (straps 1-4, lower extremity and thighs, fastened)
Device: Zoex compression garment
5-strap compression of abdomen, thighs and legs

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 12-19 years
  2. POTS diagnosis
  3. English speaking -

Exclusion Criteria:

  1. Somatic, cognitive, or psychiatric disorder that could prevent safe tilt table testing
  2. Medications that cannot be stopped/held safely for the procedure, but can cause or exacerbate orthostatic intolerance -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01795469

Locations
United States, Ohio
Nationwide Children's Hospital, neurology outpatient clinic Recruiting
Columbus, Ohio, United States, 43205
Contact: Geoffrey L Heyer, MD    614-722-4625    geoffrey.heyer@nationwidechildrens.org   
Principal Investigator: Geoffrey L Heyer, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
  More Information

No publications provided

Responsible Party: Geoffrey Heyer, Assistant Professor, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01795469     History of Changes
Other Study ID Numbers: IRB13-00033 (NCH IRB number)
Study First Received: February 18, 2013
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
POTS
Orthostatic
Adolescent

Additional relevant MeSH terms:
Syncope
Tachycardia
Postural Orthostatic Tachycardia Syndrome
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014