Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06292104

Conditions

Postural Orthostatic Tachycardia Syndrome

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

Interventions

multimodal diagnostic testing

Study Details

Brief summary:

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

Conditions

Postural Orthostatic Tachycardia Syndrome

Study ID

NCT06292104

Start date

Mar 5, 2024

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Accepted

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:

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)

Study Design

Enrollment

350 participants

Anticipated

Interventions and Outcome Measures

Arms

POTS (Postural Orthostatic Tachycardia Syndrome)

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

Healthy matched controls

Age and sex matched controls

Interventions

multimodal diagnostic testing

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

Primary outcome measure

  • Phenotyping POTS [ Time Frame: 2 weeks ]
  • Natural history [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Steve Hopkins

214-648-9275steve.hopkins@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75208

Contacts

Steven Hopkins

2146489275steve.hopkins@utsouthwestern.edu

Principal Investigator:

Steven Vernino, MD, PhD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-17.