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NCT06292104
Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)
Conditions: Postural Orthostatic Tachycardia Syndrome
Sex: All
Ages: 14 Years – N/A
Healthy volunteers: Yes
Enrollment: 350
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center Dallas Texas
Summary
This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT06292104). StuddyBuddy aggregates publicly available trial information.