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RecruitingNCT06292104Updated Jul 17, 2026

Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)

An observational study in Postural Orthostatic Tachycardia Syndrome, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-17.

Sponsored by University of Texas Southwestern Medical Center · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
350
Ages
14 Years and older
Sex
All
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Study summary

This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities.

Read the detailed description

This comprehensive multimodality deep phenotyping will improve the diagnostic approach, inform the development of new treatments, and allow the targeting of therapies to specific POTS patients. The investigators will further identify the diagnostic tools, biomarkers, and clinical outcome measures most relevant to defining the disorder in clinical practice.

The specific aim is to (1) Define clinical POTS classifications from multimodal clinical and laboratory data, (2) address exercise tolerance in POTS using metabolomic assessments, (3) evaluate novel POTS-specific patient outcome measures and (4) evaluate one year outcome data for POTS

Specific research tests will include blood work (for immunophenotyping and neurohormonal assessments), autonomic function testing, skin biopsy (to evaluate intraepidermal nerve fiber density), CO (Carbon Monoxide) rebreathing (for quantitative measurement of plasma volume and red blood cell mass), patient surveys (to characterize symptom profile and disease impact). Blood biosamples will be stored as a repository for future research questions.

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Conditions studied

  • Postural Orthostatic Tachycardia Syndrome
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In context

Postural Orthostatic Tachycardia Syndrome

131 studies on the registry are indexed under Postural Orthostatic Tachycardia Syndrome; 44 are open to participants now.

This study's planned enrollment of 350 is above the median of 100 across 31 observational studies indexed under Postural Orthostatic Tachycardia Syndrome.

Browse Postural Orthostatic Tachycardia Syndrome studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

POTS patients and Normal Control

Inclusion criteria

POTS Patients

  • Age ≥ 14 years, able to provide informed consent (assent with parental consent for age \< 18) and comply with procedures
  • Meets consensus criteria for POTS: (1) sustained increase in heart rate ≥ 30 bpm above supine baseline within 10 min of quiet standing or upright tilt (≥ 40 bpm in individuals 12 to 19 years of age) OR sustained upright HR (heart rate) >120 bpm, (2) absence of orthostatic hypotension, (3) symptoms with standing that improve with sitting or lying down, (4) resting supine heart rate \< 100 bpm, (5) orthostatic symptoms present for at least 6 months
  • Stable oral medication regimen for at least 14 days

Non-POTS Control Patients

  • Healthy women, age 18 - 30 years, able to provide informed consent and comply with study procedures
  • Does NOT meet consensus criteria for postural tachycardia syndrome
  • No symptoms of orthostatic intolerance or dysautonomia. No history of other major medical disorder
  • Resting supine heart rate \< 100 bpm

Exclusion criteria

Exclusion Criteria:

None of the following exclusion criteria:

  • Use of amphetamine-type stimulants, diuretics, selective norepinephrine reuptake inhibitor, anticholinergic medications (including tricyclic antidepressant medications), fludrocortisone, desmopressin in past 14 days
  • Use of other autonomic drugs (adrenergic agents, pyridostigmine, droxidopa, triptans, ivabradine) in past 48 hours
  • Currently receiving IVIG (Intravenous immunoglobulin), subcutaneous IgG (Immunoglobulin G), or any investigational medication (in past year)
  • Infusion of iv fluids in past 7 days
  • History or evidence of another condition explaining symptoms or orthostatic tachycardia (e.g. structural heart disease, CSF (Cerebrospinal fluid) hypovolemia, or severe traumatic brain injury)
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
350 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • POTS (Postural Orthostatic Tachycardia Syndrome)

    Patients meeting clinical criteria for postural orthostatic tachycardia syndrome who meet other criteria for inclusion.

    Diagnostic Test: multimodal diagnostic testing

  • Healthy matched controls

    Age and sex matched controls

    Diagnostic Test: multimodal diagnostic testing

Interventions

  • Diagnostic testmultimodal diagnostic testing

    Serological testing, cardiac MRI, skin biopsy, cardiovascular testing, blood volume measurements

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What researchers measure

Primary outcomes

  1. Phenotyping POTS

    Assignment of participant to a phenotypic group(s) based on analysis of multimodal data

    Time frame: 2 weeks

  2. Natural history

    Patient reported functional and subjective change. Surveys including COMPASS31 (Composite Autonomic Symptom Score-31) on a score of 0-100. Higher scores indicate more severe autonomic symptoms

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • UT Southwestern Medical Center
    Dallas, Texas 75208, United States
    Recruiting
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References and documents

Publications

  • Raj SR, Bourne KM, Stiles LE, Miglis MG, Cortez MM, Miller AJ, Freeman R, Biaggioni I, Rowe PC, Sheldon RS, Shibao CA, Diedrich A, Systrom DM, Cook GA, Doherty TA, Abdallah HI, Grubb BP, Fedorowski A, Stewart JM, Arnold AC, Pace LA, Axelsson J, Boris JR, Moak JP, Goodman BP, Chemali KR, Chung TH, Goldstein DS, Darbari A, Vernino S. Postural orthostatic tachycardia syndrome (POTS): Priorities for POTS care and research from a 2019 National Institutes of Health Expert Consensus Meeting - Part 2. Auton Neurosci. 2021 Nov;235:102836. doi: 10.1016/j.autneu.2021.102836. Epub 2021 Jun 30. PubMed 34246578 ↗
  • Bryarly M, Phillips LT, Fu Q, Vernino S, Levine BD. Postural Orthostatic Tachycardia Syndrome: JACC Focus Seminar. J Am Coll Cardiol. 2019 Mar 19;73(10):1207-1228. doi: 10.1016/j.jacc.2018.11.059. PubMed 30871704 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06292104
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Steven Vernino MD PhD (PROFESSOR, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Mar 4, 2024
Start date
Mar 5, 2024
Primary completion
Dec 2028 (estimated)
Completion
Jan 2029 (estimated)
Last update
Jul 17, 2026

Study contacts

Steve Hopkins
Contact
steve.hopkins@utsouthwestern.edu
214-648-9275
Steven Vernino, MD PhD
principal investigator · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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