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

NCT01617616 | Completed DMC

• 1 other identifier: WFUBAHA01
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Postural Orthostatic Tachycardia Syndrome; Syncope, Vasovagal; Neurocardiogenic Syncope

Outcome Measures

Primary Outcomes (1)

• Autonomic Testing in Suspected POTS Subjects

  We will address the hypothesis that elevated supine MAP accompanies the CV dysautonomia in children presenting with symptoms of POTS.

  Change in autonomic system 15 minute post baseline

Secondary Outcomes (1)

• Change in Heart Rate and Blood Pressure in Suspected POTS Subjects

  Change in Heart rate and blood pressure 15 minutes after baseline

Study Arms (4)

Normal tilt test

Patients with normal tilt table testing (they may have symptoms which precipitated the tilt, but in the end did not qualify as POTS, NMH, ETC.)

confirmed POTS diagnosis

after review of tilt table results, this group will be the confirmed postural orthostatic tachycardic syndrome group patient

Neurocardiogenic syncope on tilt

This group is comprised of patients with confirmed diagnosis of neurocardiogenic syncope on tilt

Neurally-mediated hypotension

Patients with confirmed diagnosis neurally mediated hypotension

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children between the ages of 10-21 years whose diagnostic workup for chronic unexplained nausea has unexpectedly revealed underlying cardiovascular instability manifesting as dysautonomia, primary defined as postural orthostatic tachycardia syndrome (POTS).

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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American Heart Association: collaborator

Study Sites (1)

Wake Forest University Baptist Health Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John E Fortunato, MD

  Wake Forest University Baptist Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: June 12, 2012
• Study Start: March 1, 2012
• Primary Completion: February 12, 2014
• Study Completion: February 12, 2014
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)