An observational study in POTS - Postural Orthostatic Tachycardia Syndrome, sponsored by Virginia Commonwealth University. Recruiting at 1 site in United States. Open to female participants aged 12 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Virginia Commonwealth University · Observational
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Among 92 studies in Postural Orthostatic Tachycardia Syndrome with a site in United States — 19 open to participants now, 42 under way, none of them phase 3. Postural Orthostatic Tachycardia Syndrome · United States.
Among the 92 studies in Postural Orthostatic Tachycardia Syndrome with a site in United States, this one is the 12th largest by planned enrollment of the 25 observational ones that give a count, is one of 8 that started in 2024, is one of 25 observational ones, reaches primary completion later than 25 of the 41 other live ones, and was the 79th registered.
136 studies on the registry are indexed under Postural Orthostatic Tachycardia Syndrome; 42 are open to participants now.
Browse Postural Orthostatic Tachycardia Syndrome studies →19 of the 92 studies in Postural Orthostatic Tachycardia Syndrome with a site in United States are open now. Recruiting first, the newest first:
Vanderbilt University Medical Center · Sites in United States
Ages 18+
Blueprint Medicines Corporation · Sites in United States, Belgium
Ages 18+
Stanford University · Sites in United States
Ages 18+
University of Texas Southwestern Medical Center · Sites in United States
Ages 14+ · Healthy volunteers
Scripps Translational Science Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 29 Postural Orthostatic Tachycardia Syndrome studies recruiting now, 9 (31%) set no upper age limit and 16 (55%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.
This study: 12 Years to 21 Years · female · healthy volunteers too.
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92 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 16 · Phase 2 15 · Phase 3 3 · Phase 4 1
First in 1994; this study’s year is marked. 8 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 120 is close to the median of 110 across 32 observational studies indexed under Postural Orthostatic Tachycardia Syndrome.
Median enrollment 36 across the 67 interventional studies, 100 across the 25 observational. Of the 49 that completed or were terminated, 19 (39%) have results posted.
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7 of 92 have an industry lead sponsor. The 10 most frequent:
Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
Virginia Commonwealth University has 3 studies filed under Postural Orthostatic Tachycardia Syndrome — fewer than ten, so there is no comparison to draw.
11 of the studies in Postural Orthostatic Tachycardia Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00962728Alfredo GamboaBreathing Device in Postural Orthostatic Tachycardia Syndrome (POTS) | 2026-11 |
| NCT07197905Vanderbilt University Medical CenterRestoring Iron Deficiency in POTS | 2026-12 |
| NCT01988883Vanderbilt University Medical CenterModafinil and Cognitive Function in POTS | 2026-12 |
| NCT01783288Vanderbilt UniversityAldosterone & Sodium Regulation in Postural Tachycardia Syndrome - Screening | 2026-12 |
| NCT05618054Virginia Commonwealth UniversityPeriaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities? | 2026-12 |
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Among the 92 studies in Postural Orthostatic Tachycardia Syndrome with a site in United States, from their registry updates:
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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.
The current definition of POTS highlights the peripheral mechanistic emphasis of 30 years of studies exploring cardio- and cerebro-vascular, immunologic, mast cell activation, connective tissue and other physiologic mechanisms. The classification of POTS itself also assumes a peripheral etiology, typically including neuropathic, hyperadrenergic, hypovolemic and sometimes immune POTS. However, a central nervous system (CNS) etiology might better account for what is knowns about POTS currently: (1) POTS often follows an infection, physical or psychological trauma. (2) POTS occurs most often in post-menarche adolescent girls volume redistribution differs across subjects (4) exercise, cognitive behavioral therapy provide best long-term outcomes (5) co-morbid disorders, typically overlapping pain conditions such as migraine headache, fibromyalgia, and most functional gastrointestinal disorders (FGID), often dominate the clinical picture. COPCs are typically considered to reflect a CNS etiology.
Because it coordinates the autonomic, motor and pain responses to an acute threat, the midbrain periaqueductal gray region (PAG) is an attractive candidate whose dysfunction could potentially explain all major features of POTS, including the frequent antecedent emotional or physical threat, the POTS core autonomic changes, and the co-morbid pain disorders. The PAG interprets threats as escapable or inescapable, specifically activating a different column for each response type.
The study aims to recruit only females aged 12-21. Females will be targeted specifically since POTS is more common in females than males and avoids creation of a subgroup too small to analyze.
POTS sample
Inclusion Criteria:
Exclusion Criteria:
POST INFECTION
Inclusion Criteria:
Exclusion Criteria:
HEALTHY CONTROLS
Inclusion Criteria:
Exclusion Criteria:
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.
Behavioral: Questionnaires to be competed · Behavioral: Provide list of medication and lifetime events · Behavioral: Use phone App to record new life events · Device: Will wear an activity monitor · Other: Periodic 24-hour urine sodium check · Diagnostic Test: A fMRI scan · Diagnostic Test: A bedside tilt test will be performed · Other: IV placed to collect blood samples · Other: Stool Sample
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.
Behavioral: Questionnaires to be competed · Behavioral: Provide list of medication and lifetime events · Behavioral: Use phone App to record new life events · Device: Will wear an activity monitor · Diagnostic Test: A fMRI scan · Diagnostic Test: A bedside tilt test will be performed · Other: IV placed to collect blood samples · Other: Stool Sample
Healthy control participants will be recruited from local communities using flyers, social media and using EPIC Best Practice Alerts.
Behavioral: Questionnaires to be competed · Behavioral: Provide list of medication and lifetime events · Behavioral: Use phone App to record new life events · Device: Will wear an activity monitor · Diagnostic Test: A fMRI scan · Diagnostic Test: A bedside tilt test will be performed · Other: IV placed to collect blood samples · Other: Stool Sample
* 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)
Participants will provide a list of all medications taken at each visit time, lifetime history of infections, traumas, and other significant 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
Participants will have an activity monitor loaned for the duration of the study to track their physical activity.
POTS patients will have a periodic 24-hour urine sodium check to determine compliance to intake of salt.
• 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 where blood pressure will be recorded supine and upright positions to confirm/exclude POTS.
• 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.
• 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
Functional Disability Inventory (FDI)
The total score determines the level of functional disability, in which higher numbers represent a higher level of disability. There are 15-items and a score of 0 indicates that there are no complaints present whereas 30 indicates that the patient is extremely disabled. The Functional Disability Inventory (FDI) is one of the most widely used measures of functional impairment among children and adolescents with chronic pain. It is expected that there will be higher threat sensitivity that correlates with POTS severity (FDI score) across the POTS cohort, and within subjects based on clinical evolution.
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
The Pain Coping Questionnaire (PCQ) is a 39-item self-report measure for evaluating pain coping in children and adolescents in both clinical and research settings. It consists of 8 subscales that can be categorized into 3 higher-order factors, including approach (composed of information seeking, problem-solving, and seeking social support subscales), problem-focused avoidance (composed of positive self-statements, behavioural distraction, and cognitive distraction subscales), and emotion-focused avoidance (composed of externalizing and internalizing/catastrophizing subscales). Higher scores indicate higher use of a particular coping strategy or style.
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)
The Pain Catastrophizing Scale for Children (PCS-C) is a 13-item self-report scale that measures how children think negatively about pain. The PCS-C asks respondents to rate how often they have pain-related thoughts and feelings on a scale of 0-4, with 0 meaning "not at all true" and 4 meaning "very true". The PCS-C is scored 1) Total score: The sum of all responses, ranging from 0-52, with higher scores indicating more catastrophic thinking 2) Subscale scores: The PCS-C assesses three dimensions of pain catastrophizing: rumination, magnification, and helplessness
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.
Functional MRI is a type of MRI scan that can show which areas of your brain are most active. Tracking and comparing that activity to what you were doing at the time can help "map" your brain activity. It's most often used for planning surgery or similar procedures in the brain. Functional MRI (fMRI) scan in this study will be completed while completing 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
A tilt table test, also known as a tilt test, is a procedure that helps determine the cause of fainting or near fainting spells. It involves lying on a table that's tilted to different positions while a medical professional monitors your heart rate, blood pressure, and oxygen levels.
Time frame: Experimental cohort: Baseline, 3, 6, 12, 24 month in person visits. Control Cohort: Baseline, 3, 6, and 12 month in person visits.
Started May 2024 (actual). Primary completion is estimated for Jul 2028, 50 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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