Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT06292104
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT06292104
Study Brief:
Protocol Section:
NCT06292104