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Postural Orthostatic Tachycardia SyndromePOTSNCT01617616

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

An observational study of Postural Orthostatic Tachycardia Syndrome and Syncope, Vasovagal, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 21 years
How many people
48 participants
Where
1 siteUnited States
Study dates
Mar 2012to 12 Feb 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University Baptist Health Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Tilt Table and Autonomic Testing in Suspected 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 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.

Read the detailed description

Dysautonomia resulting in decreased HRV and impaired BRS, which may be accompanied by supine hypertension, is known to play a role in the development and progression of hypertension, which can lead to hypertensive heart disease including left ventricular hypertrophy and congestive heart failure as well as cardiovascular problems such as stroke, 4-6. The long-term cardiovascular consequence of decreased HRV and impaired BRS when present in childhood is not known, but in experimental models of cardiovascular dysfunction, the BRS and HRV impairments precede the eventual elevation in MAP 7. Dysautonomia with symptoms of OI is found in nearly 500,000 Americans with approximately 15% of all children experiencing syncope before the end of adolescence 8, 9. The majority of these individuals will not develop severe autonomic failure disorders as adults (pure autonomic failure or multiple system atrophy), but whether they are at greater cardiovascular risk for hypertension, stroke or cardiac hypertrophy and heart failure is not known.

Our preliminary findings in children presenting to our GI clinic with chronic unexplained nausea show that dysautonomia manifesting as OI triggered nausea in 15 of 17 patients, and that nausea in these subjects substantially improved after the aldosterone agonist fludrocortisones 1. These children exhibit predominately POTS1, in contrast to syncope and neurally mediated hypotension (NMH) typically seen in pediatric cardiology clinics10. POTS is an autonomic disorder characterized by excessive increase in heart rate (HR) upon upright posture 11. It may present with palpitations, shortness of breath, nausea, lightheadedness, and syncope. Fludrocortisone acetate is a standard treatment for the orthostatic symptoms associated with POTS, thought to be a volume expander and to offset the low aldosterone reported in adults with OI 12, 13 . This is not the first time an association between OI and gastrointestinal symptoms has been described. Posturally mediated heart rate (HR) changes resulting in abnormal gastric electrical activity in patients with functional abdominal pain has recently been shown in children14. While it may seem that nausea and other GI symptoms are not relevant to CV disease and the AHA, our preliminary data suggest that treatment to remedy the CV dysautomomia also reduces the chronic unexplained nausea in a majority of these children without correcting the gastric dysrhythmias, suggesting the nausea is secondary to the CV dysatuonomia. However, there is a significant knowledge and therapy gap in this field as the cause and pathophysiologic mechanism(s) of either the chronic nausea or the POTS in this group remains essentially undefined. Furthermore, we recognized that the treatment for OI associated nausea, such as alpha or aldosterone agonists, may alleviate gastrointestinal symptoms, but exacerbate undefined cardiovascular pathology through multiple mechanisms.

Therefore, our immediate goal is a better understanding of the specific autonomic disturbances in patients with chronic unexplained nausea to allow more timely and better selection of drugs to manage both the GI and CV symptoms in these subjects. In the past year, we have used the combination of tilt table and continuous autonomic assessment to provide more complete data on autonomic profile of these subjects, including baroreflex sensitivity for control of HR (BRS), heart rate variability (HRV) and blood pressure variability (BPV). The head-up tilt mimics daily life stressors (upright posture/standing) and the response pattern provides additional diagnostic information important for patient management. Our preliminary findings show that supine MAP is elevated in the subjects with POTS compared with the control group (those with nausea but having a normal tilt test). In addition, during upright posture BRS and HRV are impaired ~50% in normal subjects, whereas >80% suppression of BRS occurs in the POTS subjects 2, 3, suggesting that BRS suppression may lead to or at least play a permissive role in the inappropriate orthostatic blood pressure and HR regulation in these children.

The use of non-invasive hemodynamic monitoring devices has proven to increase the sensitivity of tilt table testing in children with unexplained syncope10. Indeed, both BRS and HRV were suppressed to a greater degree in subjects with OI. Interestingly, in this series in which children were recruited from a pediatric cardiology clinic, the majority of patients (61%) were diagnosed with neurally mediated hypotension (NMH); whereas, in our series, most patients (68%) had POTS. Therefore, for this proposal, patients will be recruited from both pediatric gastroenterology and cardiology clinics to maximize the number of patients in each respective CV dysautonomia subgroup: POTS, NMH, or neurocardiogenic syncope.

While fludrocortisone treatment resulted in symptomatic relief of both nausea and OI in our patients, it may not be the optimal long-term agent for children with OI particularly because indefinite use of fludrocortisone may pose musculoskeletal and endocrine risks, chronic headaches and electrolyte problems such as hypokalemia 15, 16. The cardiovascular effects associated with long-term use of fludrocortisone in children are not known, but experimental data clearly implicate excess aldosterone with and without elevated angiotensin II with increased fibrosis in heart and kidney and cardiac hypertrophy, as well as hypertension 6 . Elevated levels of aldosterone have been associated with secondary hypertension as well as impaired baroreflex sensitivity in the hypertensive state17, 18. Our preliminary findings suggest abnormalities in BRS during the tilt in the children with POTS, which improves but does not correct with fludrocortisone. Of greater concern is the higher supine MAP in children with POTS compared to those without POTS. While our data do not show further elevation in supine MAP with fludrocortisone treatment in our small sample, other blood pressure elevating treatments, such as vasoconstrictors that have also been empirically used to treat OI do elevate the supine MAP 15, 19. However, blockade of aldosterone has cardiovascular benefits independent of lowering blood pressure 20 suggesting that even if aldosterone does not further elevate supine MAP, excess aldosterone may be detrimental to cardiovascular health. In adults, increasing evidence suggests that angiotensin II concentrations in plasma may be elevated in OI 21, which could contribute to suppression of the BRS. The abnormalities in the renin-angiotensin-aldosterone axis and in the levels of catecholamines in adult patients12, 21 are used to direct treatments, including use of beta-blockers or exercise for the tachycardia seen with POTS 22 Because we do not have a neurohumoral profile defined in these children, an evidence-based choice of medications is often absent. Therefore, in addition to elucidating the specific role of the sympathetic versus parasympathetic nervous system by HR changes and differences in BRS, BPV and HRV during tilt, we believe it is essential to better define neurohumoral characteristics of patients with CV dysautonomia to attempt to understand the mechanism for OI. While this has been performed in adults, it has not been described in children to date23. Perhaps, more importantly, understanding the autonomic neurohumoral profile in patients with CV dysautonomia may allow more directed and safer treatment with less risk for cardiovascular side effects, such as exacerbation of supine hypertension.

Medical subject headings
Postural Orthostatic Tachycardia Syndrome, Syncope, Vasovagal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01617616
Study groupRoleWhat they receive
Normal tilt testPatients 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 diagnosisafter review of tilt table results, this group will be the confirmed postural orthostatic tachycardic syndrome group patient
Neurocardiogenic syncope on tiltThis group is comprised of patients with confirmed diagnosis of neurocardiogenic syncope on tilt
Neurally-mediated hypotensionPatients with confirmed diagnosis neurally mediated hypotension

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change in autonomic system 15 minute post baseline

Secondary outcomes (1)
  1. Change in Heart Rate and Blood Pressure in Suspected POTS Subjects

    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.

    Measured: Change in Heart rate and blood pressure 15 minutes after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2012 (estimated)
  2. Study startMar 2012
  3. Primary completion12 Feb 2014
  4. Study completion12 Feb 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01617616
Sponsor's protocol ID
WFUBAHA01
Acronym
POTS
Status last verified
Apr 2017
First submitted
10 Apr 2012
Last updated
20 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Postural Orthostatic Tachycardia Syndrome and Syncope, Vasovagal, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Autonomic Testing in Suspected POTS Subjects (time frame: Change in autonomic system 15 minute post baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2017.

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