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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
John Fortunato, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT01617616
First received: April 10, 2012
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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.


Condition
Postural Orthostatic Tachycardia Syndrome
Syncope, Vasovagal
Neurocardiogenic Syncope

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tilt Table and Autonomic Testing in Suspected POTS Subjects

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Autonomic Testing in Suspected POTS Subjects [ Time Frame: Change in autonomic system 15 minute post baseline ] [ Designated as safety issue: No ]
    We will address the hypothesis that elevated supine MAP accompanies the CV dysautonomia in children presenting with symptoms of POTS.


Secondary Outcome Measures:
  • Change in Heart Rate and Blood Pressure in Suspected POTS Subjects [ Time Frame: Change in Heart rate and blood pressure 15 minutes after baseline ] [ Designated as safety issue: No ]
    We will identify neurohumoral characteristics for each group to establish the underlying mechanisms for the elevated supine MAP and the dysautonomia in these subjects leading to a more focused approach to treatment.


Estimated Enrollment: 48
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01617616

Locations
United States, North Carolina
Wake Forest University Baptist Health Center
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
American Heart Association
Investigators
Principal Investigator: John E Fortunato, MD Wake Forest University Baptist Health Center
  More Information

No publications provided

Responsible Party: John Fortunato, Pediatric Gastroenterologists, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT01617616     History of Changes
Other Study ID Numbers: WFUBAHA01
Study First Received: April 10, 2012
Last Updated: March 27, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014