Recruiting

Observational Study

Sponsor:

Virginia Commonwealth University

Code:

NCT06616363

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex: Female

Age: 12 - 21

Healthy Volunteers: Accepted

Interventions

Questionnaires to be competed

Provide list of medication and lifetime events

Use phone App to record new life events

Will wear an activity monitor

Periodic 24-hour urine sodium check

Study Details

Brief 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.

Conditions

POTS - Postural Orthostatic Tachycardia Syndrome

Study ID

NCT06616363

Start date

May 29, 2024

Status verified date

Sep, 2025

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 12 - 21

Healthy Volunteers: Accepted

POTS sample

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Cognitive defects that preclude answering questionnaires or following assessment directions
  • Other chronic diseases
  • Unstable medical conditions
  • Use of narcotics
  • Limited English proficiency
  • Investigator discretion that participant would not be suitable to participate
  • A phone older than 5 years old or unable to support EMA software

POST INFECTION

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Chronic prescriptions, history of POTS or orthostatic symptoms, recent inpatient psychiatric admissions, substance use disorder, trauma such as a motor vehicle accident, surgery, or other significant physical or emotional trauma in the last 5 years
  • Cognitive defects that preclude answering questionnaires or following assessment directions
  • Other unstable chronic diseases
  • Unstable medical conditions
  • Use of narcotics
  • Severe depression or anxiety (untreated / unstable)
  • Limited English proficiency
  • Investigator discretion that participant would not be suitable to participate
  • A phone older than 5 years old or unable to support EMA software

HEALTHY CONTROLS

Inclusion Criteria:

  • Apparently healthy with no known chronic illnesses

Exclusion Criteria:

  • Pregnant or breastfeeding
  • History of POTS or orthostatic symptoms, migraines, fibromyalgia, chronic fatigue, PTSD. Functional gastrointestinal disorders, fainting, dysmenorrhea, or other chronic pain syndrome, inpatient psychiatric admissions, substance use disorder, trauma such as a motor vehicle accident, surgery, or other significant physical or emotional trauma in the last 5 years
  • Cognitive defects that preclude answering questionnaires or following assessment directions
  • Other chronic unstable diseases
  • Unstable medical conditions
  • Use of narcotics
  • Severe depression or anxiety (untreated / unstable)
  • Limited English proficiency
  • Investigator discretion that participant would not be suitable to participate
  • A phone older than 5 years old or unable to support EMA software

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Questionnaires to be competed

  • The Pain Coping Questionnaire short form
  • Functional Disability Inventory (FDI), the primary clinical outcome measure.
  • COMPASS-31 and orthostatic hypotension modified for POTS.
  • The Pain Response Inventory (PRI)PROMIS Depression
  • GAD-7 for anxiety
  • Varni/Thompson Pediatric Pain Questionnaire
  • Child and Parent Reports of Post-Traumatic Symptoms (CROPS/PROPS)
  • Pain Catastrophizing Scale (PCS-C)
  • Detailed account of natural history and evolution of POTS and COPCs through MEDYSA (facilitates the assessment of specific syndromic diagnoses based on published criteria, rather than organ-based classification of symptoms)

Provide list of medication and lifetime events

Participants will provide a list of all medications taken at each visit time, lifetime history of infections, traumas, and other significant life events.

Use phone App to record new life events

Subjects will also record new life events, minor traumas, entrance into a flare and menses in Ilumivu's EMA (Ecological Momentary Assessment) phone App

Will wear an activity monitor

Participants will have an activity monitor loaned for the duration of the study to track their physical activity.

Periodic 24-hour urine sodium check

POTS patients will have a periodic 24-hour urine sodium check to determine compliance to intake of salt.

A fMRI scan

• Participants will complete a fMRI scan without contrast and complete a looming animacy threat task; participants judge the valence of images via button press as they perceive the image.

A bedside tilt test will be performed

A bedside tilt test will be performed where blood pressure will be recorded supine and upright positions to confirm/exclude POTS.

IV placed to collect blood samples

• An IV will be place for collection of 4 blood samples, about 12 mL of blood. For each position (lying and standing) the study team will draw 2 tubes each times with 3 mL of blood, for a total of 4 lab tubes (12 mL). Physical exams to assess the 18-tender points described by the American College of Rheumatology for the diagnosis of fibromyalgia and hypermobility/Ehlers-Danlos Syndrome (EDS) exam will be performed in all subjects.

Stool Sample

• Participants will provide a stool biospecimen sample at each in-person visit. Stool will be collected in a hat and sample will be swabbed with the swab placed directly into PrimeStore collection tube and the remainder of the sample discarded

Primary outcome measure

  • Functional Disability Inventory (FDI) [ Time Frame: Experimental Cohort: Baseline and monthly for 24 months (3, 6, 12, 24 in-person study visits), the other months will be completed from home. The control cohort: months 0-12 ]
  • Pain Coping Questionnaire short form [ Time Frame: Experimental Cohort: Baseline and monthly for 24 months (3, 6, 12, 24 in-person study visits), the other months will be completed from home. The control cohort: months 0-12 ]
  • Pain Catastrophizing Scale (PCS-C) [ Time Frame: Experimental Cohort: Baseline and monthly for 24 months (3, 6, 12, 24 in-person study visits), the other months will be completed from home. The control cohort: months 0-12 ]
  • Functional MRI (fMRI) scan while completing a complete a looming animacy threat task; participants judge the valence of images via button press as they perceive the image. [ Time Frame: Experimental cohort: Baseline, 3, 6, 12, 24 month in person visits. Control Cohort: Baseline, 3, 6, and 12 month in person visits. ]
  • Bedside Tilt test [ Time Frame: Experimental cohort: Baseline, 3, 6, 12, 24 month in person visits. Control Cohort: Baseline, 3, 6, and 12 month in person visits. ]

Central Contacts and Locations

Central contacts

Gisela Chelimsky

804-827-3427Gisela.Chelimsky@vcuhealth.org

Bhakti Dave

804-827-3427Gisela.Chelimsky@vcuhealth.org

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Gisela Chelimsky

804-827-3427Gisela.Chelimsky@vcuhealth.org

Bhakti Dave,

804-828-7802bhakti.dave@vcuhealth.org

Principal Investigator:

Gisela Chelimsky

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • PAG activation
  • Cardiovagal Modulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2025-09-26.