NCT06292104 Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)
| NCT ID | NCT06292104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Postural Orthostatic Tachycardia Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2024-03-05 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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)
Contact & Investigator
Steven Vernino, MD PhD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06292104 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Postural Orthostatic Tachycardia Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06292104 currently recruiting?
Yes, NCT06292104 is actively recruiting participants. Contact the research team at steve.hopkins@utsouthwestern.edu for enrollment information.
Where is the NCT06292104 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06292104 clinical trial?
NCT06292104 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Steven Vernino, MD PhD at University of Texas Southwestern Medical Center. The trial plans to enroll 350 participants.