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NCT01617616 · ClinicalTrials.gov registry record
Tilt Table With Suspected Postural Orthostatic Tachycardia Syndrome (POTS) Subjects
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 48
- Enrollment target
NCT01617616: Completed study, sponsored by Wake Forest University Health Sciences.
NCT01617616 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 48 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01617616 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 48 participants
- Enrollment target
Study Summary
Dysautonomia, primarily defined as postural orthostatic tachycardia syndrome (POTS) can seriously disrupt a child's daily activities. It is most commonly associated with nausea or abdominal pain. In preliminary studies, when orthostatic intolerance was treated with fludrocortisone, a standard therapy for orthostatic intolerance (OI), symptomatic improvement in nausea was observed. However, children with POTS were also observed to have higher supine mean arterial pressure (MAP) (preliminary data) and greater suppression of the baroreceptor reflex sensitivity (BRS) occurred upon up-right tilt. While fludrocortisone alleviates nausea associated with OI, its long-term use may pose long term health risks to children including worsening hypertension. Therefore, it is the objective of this study to define the mechanism for OI as it relates to nausea. The investigators hypothesize that OI resulting from changes in the autonomic nervous system is the likely mechanism for the nausea observed in the patients in this study. The investigators further hypothesize that this is potentially an early marker for future cardiovascular problems such as early onset hypertension and cardiac hypertrophy. The general objective of this protocol is to address this gap in knowledge by determining the autonomic characteristics of children with OI as well as defining neurohumoral profiles for these subjects to better understand the cause of the elevated supine in these subjects. By better understanding the potential mechanism for this condition, it is the investigators future goal to develop a more focused and safer treatment strategy. The investigators will study subjects between 10 to 18 years of age utilizing the tilt table to mimic daily life stressors and also measure serum levels of epinephrine, norepinephrine, rennin, angiotensin II, aldosterone, and vasopressin at baseline and during tilt. This study will generate data with high impact in that more rational treatments for management of d
Primary Outcome
We will address the hypothesis that elevated supine MAP accompanies the CV dysautonomia in children presenting with symptoms of POTS.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-02-12 |
What the finished NCT01617616 record still lists
NCT01617616 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 48 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01617616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01617616 about?
NCT01617616 is a clinical study titled "Tilt Table With Suspected Postural Orthostatic Tachycardia Syndrome (POTS) Subjects". Dysautonomia, primarily defined as postural orthostatic tachycardia syndrome (POTS) can seriously disrupt a child's daily activities. It is most commonly associated with nausea or abdominal pain. In preliminary studies, when orthostatic intolerance was treated with fludrocortisone, a standard therap...
What is the current status of trial NCT01617616?
This trial is currently completed. The enrollment target is 48 participants. The study started on 2012-03. Estimated completion is 2014-02-12.
Who is sponsoring clinical trial NCT01617616?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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