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NCT01795469 · ClinicalTrials.gov registry record · NA
Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients
A NA study of Syncope and Postural Orthostatic Tachycardia Syndrome (POTS), sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01795469: Completed NA study of Syncope and Postural Orthostatic Tachycardia Syndrome (POTS), sponsored by Nationwide Children's Hospital.
NCT01795469 is a NA study of Syncope and Postural Orthostatic Tachycardia Syndrome (POTS) that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 20 participants, below the 849-participant average among 11 other Syncope trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01795469, a NA study of Syncope and Postural Orthostatic Tachycardia Syndrome (POTS), has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE Zoex compression garment
Study Locations (1)
Ohio
- Nationwide Children's Hospital, neurology outpatient clinic - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-02 |
| Phase | NA |
What the finished NCT01795469 record still lists
NCT01795469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 849-participant average among 11 other Syncope trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Syncope appearing as the primary indexed condition, and to 1 intervention - of which Zoex compression garment is the first listed.
NCT01795469 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01795469 about?
NCT01795469 is a clinical study titled "Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients". 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 be...
What is the current status of trial NCT01795469?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-02. Estimated completion is 2016-02.
What conditions does trial NCT01795469 study?
This clinical trial studies the following conditions: Syncope, Postural Orthostatic Tachycardia Syndrome (POTS).
What interventions are being tested in trial NCT01795469?
The interventions under investigation include: Zoex compression garment (DEVICE).
Who is sponsoring clinical trial NCT01795469?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01795469 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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