Tilt Table With Suspected Postural Orthostatic Tachycardia Syndrome (POTS) Subjects

Completed

Conditions studied: Postural Orthostatic Tachycardia Syndrome, Syncope, Vasovagal, Neurocardiogenic Syncope

In brief

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 dysautonomia could be chosen on the basis of the profile of dysautonomia and neurohumoral markers.

Key facts

Study ID

NCT01617616

Run by

Wake Forest University Health Sciences

People needed

48

Starts

2012-03-01

Expected to finish

2014-02-12

Last updated by the study team

2017-04-20

Who can join

Age: 10 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 10-21 years of age
• Must meet Rome III criteria for childhood functional dyspepsia with nausea as the predominant symptom
• Must complete nausea and anxiety questionnaires
• Patients from the pediatric cardiac clinic who present with symptoms of unexplained syncope not associated with cardiac anatomic anomalies or other identified cardiac pathology

You may not qualify if…

• Patients with gastrointestinal symptoms due to metabolic, mechanical or mucosal inflammation, including a diagnosis of inflammatory bowel disease, celiac disease, liver or pancreatic disease, hiatal hernia, or bowel obstruction.
• Patients who are incapable or unwilling to discontinue medications affecting autonomic function.
• Patients with significant cardiac or cardiovascular disease, malignancy, or other co-morbid conditions precluding successful completion of a 45 minute tilt test.
• Patients with diabetes.

Where it is running

• Wake Forest University Baptist Health Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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