(PAG POTS - NIH) Pediatric Postural Orthostatic Tachycardia Syndrome (POTS) : Does a Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities?

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Diagnostic test, Other, Device
Study Type: Observational
SUMMARY

Postural tachycardia syndrome (POTS) is a common and disabling disorder among adolescents. No epidemiologic data exist to support the often cited 0.5 to 2% prevalence. Case series suggest 3 to 5 times greater incidence in girls than boys. POTS is defined in children as daily chronic symptoms of orthostatic intolerance and a 40 bpm rise in heart rate in the first 10 minutes of a tilt study in the absence of orthostatic hypotension. POTS often develops after an acute event like an illness, infection, immunization, head trauma, psychological trauma or surgery. Natural history data are absent for POTS, though some outcome studies exist. Orthostatic symptoms improve in the majority and heart rate changes improve in 38% at 1 year. A 2-year follow up showed small improvement in comorbid symptoms of POTS in a 12 subject cohort followed yearly. In a pediatric 5-year outcome follow up questionnaire study, 86% of adolescents with POTS reported resolved, improved, or intermittent, symptoms, with primarily physical rather than mental health complaints.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 12
Maximum Age: 21
Healthy Volunteers: t
View:

• symptomatic ≥ 40 bpm rise in heart rate in the first 10 min of a tilt table study without a drop in blood pressure

• Clinical symptoms of orthostatic intolerance

• acute upper respiratory or gastrointestinal infection that required admission to the acute care units but not requiring an ICU stay

• Apparently healthy with no known chronic illnesses

Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Gisela Chelimsky
Gisela.Chelimsky@vcuhealth.org
804-827-3427
Backup
Bhakti Dave
Gisela.Chelimsky@vcuhealth.org
804-827-3427
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2028-07
Participants
Target number of participants: 120
Treatments
60 POTS Postural Tachycardia Syndrome (POTS)
POTS patients will be current patients of the study practitioners within the autonomic, cardiology PM\&R clinics and autonomic laboratory. This cohort may receive a codified treatment plan within the following 7 treatment categories which are also standard of care procedures based on clinical recommendations: (1) salt, fluid and diet management; (2) exercise program with or without PT; (3) cognitive behavioral therapy or other counseling; (4) vagal stimulation forms like yoga, breathing exercises, relaxation, microauricular stimulation; (5) pharmacotherapy for pressure maintenance; (6) medications for pain and headache; (7) medications for the gastrointestinal issues.
40 Post-Infection cohort
Post-Infection participants will be identified through Best Practice Alerts through EPIC, and referrals from hospitalist and gastroenterology inpatient services. Post-Infection cohorts will be approached up to 6 weeks after they are released from the hospital, to ensure they are healthy enough to participate.
20 healthy controls
Healthy control participants will be recruited from local communities using flyers, social media and using EPIC Best Practice Alerts.
Sponsors
Leads: Virginia Commonwealth University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials