RecruitingNCT06292104

Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)

Multimodality Deep Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS), Aim 1


Sponsor

University of Texas Southwestern Medical Center

Enrollment

350 participants

Start Date

Mar 5, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 14 Years

Inclusion Criteria9

  • 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 Criteria5

  • 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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Interventions

DIAGNOSTIC_TESTmultimodal diagnostic testing

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


Locations(1)

UT Southwestern Medical Center

Dallas, Texas, United States

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NCT06292104


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