NCT02725060
Autoimmune Basis for Postural Tachycardia Syndrome
Enrolling by Invitation
NAAges 18–50InterventionalVanderbilt University Medical CenterInvestigator-initiated
~58 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:phenylephrineisoproterenol25 micro-Ci of radiationPosture study with blood samples24-hour heart rhythm and blood pressure monitoringQuantitative Axonal Sudomotor Reflex Testing
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Autoantibody levels
Measured over up to 10 minutes
+3 more outcomes measured
Conditions
Where it's being run
2 sites across 2 statesOklahoma1
Tennessee1
Study leadership
- Luis Okamoto, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
18-50 years old
Postural Tachycardia Syndrome: Heart rate increase \>30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (\>20/10 mmHg fall in blood pressure), with chronic symptoms (\> 6 months), and in the absence of other acute cause of orthostatic tachycardia.
Able and willing to provide informed consent
Female premenopausal subjects must utilize adequate birth control and willingness to undergo serum beta-hCG testing
The subject must understand and be able to comply with the study procedures and restrictions.
Exclusion
Hypertension (\>150 mmHg systolic and \>100 mmHg diastolic) based on history or findings at screening.
Orthostatic hypotension (consistent drop in blood pressure \>20/10 mmHg with 10 min stand)
Pregnancy
Cardiovascular disease, such as myocardial infarction within 6 months, angina pectoris, significant arrhythmia (sinus tachycardia is not excluded), deep vein thrombosis, pulmonary embolism
History of serious neurologic disease
History or presence of significant immunological or hematological disorders
Clinically significant gastrointestinal impairment that could interfere with dietary compliance or drug absorption
Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase \>1.5 x upper limit of normal range)
Impaired renal function (serum creatinine \>1.5 mg/dL)
Hematocrit \<28%
Current or concurrent disease that could affect the absorption, action or disposition of the drug, or clinical or laboratory assessments.
Any underlying or acute disease requiring regular medication that could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
Inability to comply with the protocol
What this trial measures
- Autoantibody levelsup to 10 minutes
Blood samples collected while supine during the posture study will be analyzed for autoantibody positivity in POTS patients and control subjects.
- Blood pressure after phenylephrine boluses1-2 minutes after bolus injections
- Heart rate after isoproterenol boluses1-2 minutes after bolus injections
- Orthostatic change in heart rateup to 10 minutes
Difference between standing and supine heart rates.