Clinical Trials Logo

Clinical Trial Summary

The investigators aim to study whether the Compensatory Reserve Index (CRI) (an FDA approved device that assesses intravascular volume) can be used to evaluate severity of Postural Orthostatic Tachycardia Syndrome (POTS) and whether the CRI value has a correlation with severity of psychosocial symptoms and functional impairment associated with POTS.


Clinical Trial Description

Autonomic dysfunction (or dysautonomia) describes several medical conditions linked to the autonomic nervous system. One of these is Postural Orthostatic Tachycardia Syndrome (POTS). In pediatric populations, symptoms of autonomic dysfunction include an increase in heart rate when standing up (tachycardia), dizziness, nausea, vomiting, fatigue, headaches, abdominal discomfort, and sleep disturbances. POTS is specifically characterized by orthostatic intolerance and a forty beats per minute (bpm) increase in heart rate upon standing. The etiology of POTS is poorly understood, and there is limited literature on the management of POTS in pediatric populations. In the U.S., POTS is estimated to affect 1-3 million people. The ability of the CRI algorithm to accurately distinguish individuals with varying tolerances to reduced central blood volume can be attributed to a unique function of the algorithm, which analyzes and compares the entirety of each waveform in a window of time to trend subtle features that correspond with varying degrees of central volume loss. CRI can also detect vascular changes associated with postural orthostatic tachycardia syndrome. CRI will be evaluated in subjects at supine and standing positions along with traditional orthostatic measures. Following CRI measurements, subjects and their parents will be asked to complete a series of surveys to assess their psychosocial symptoms and functional impairment. The CRI measurement and survey completion will occur over the course of one clinic visit. ;


Study Design


Related Conditions & MeSH terms

  • Postural Orthostatic Tachycardia Syndrome
  • Tachycardia

NCT number NCT03974737
Study type Observational
Source University of Colorado, Denver
Contact
Status Completed
Phase
Start date June 1, 2019
Completion date September 22, 2020

See also
  Status Clinical Trial Phase
Recruiting NCT05555771 - Paediatric Syncope in the Emergency Department N/A
Recruiting NCT05923840 - Chemoreflex and Baroreflex Alterations Causing Postural Tachycardia Syndrome With Orthostatic Hyperpnea and Hypocapnia N/A
Completed NCT05633407 - Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS Phase 2
Completed NCT03930914 - Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome N/A
Recruiting NCT00865917 - Cardiovascular Effects of Selective I(f)-Channel Blockade Phase 2
Recruiting NCT05741112 - The Long COVID-19 Wearable Device Study N/A
Recruiting NCT05454137 - A Shared Medical Appointment Intervention for Quality of Life Improvement in POTS N/A
Recruiting NCT05924646 - CAlgary SAlt for POTS N/A
Enrolling by invitation NCT05877534 - Effects of Individual Tailored Physical Exercise in Patients With POTS After COVID-19 - a Randomized Controlled Study N/A
Recruiting NCT06268288 - Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS) N/A
Completed NCT01367977 - Head Circumference Growth in Children With Ehlers-Danlos Syndrome Who Develop Dysautonomia Later in Life
Recruiting NCT04881318 - Compression Garments in the Community With POTS N/A
Recruiting NCT06292104 - Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)
Completed NCT02171988 - Effect of Medical Treatment and Prognosis of Postural Orthostatic Tachycardia Syndrome (POTS) Phase 4
Completed NCT01563107 - Dietary Sodium's Effect on Urinary Sodium and Dopamine Excretion in Patients With Postural Tachycardia Syndrome N/A
Completed NCT01617616 - Tilt Table With Suspected Postural Orthostatic Tachycardia Syndrome (POTS) Subjects N/A
Completed NCT01547117 - Dietary Salt in Postural Tachycardia Syndrome N/A
Active, not recruiting NCT02281097 - Transdermal Vagal Stimulation for POTS N/A
Completed NCT00728026 - Autonomic Profiles in Pediatric Patients With Cyclic Vomiting Syndrome (CVS), Irritable Bowel Syndrome (IBS),Postural Orthostatic Tachycardia Syndrome (POTS), Functional Abdominal Pain (FAP) or Chronic Nausea N/A
Recruiting NCT05481177 - Ivabradine for Long-Term Effects of COVID-19 With POTS Cohort Phase 4