Autoimmune Basis for Postural Tachycardia Syndrome
NCT02725060 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2025-11-12
Summary
The purpose of this study is to see if some people with postural tachycardia syndrome (POTS) have higher levels of immune proteins (autoantibodies) directed against receptors of the autonomic nervous system, and if these autoantibodies make a difference in their POTS symptoms. The investigators also want to see if the levels of these autoantibodies stay the same over time.
Conditions
- Postural Orthostatic Tachycardia Syndrome
- Postural Tachycardia Syndrome
- Tachycardia
- Arrhythmias, Cardiac
- Autonomic Nervous System Diseases
- Orthostatic Intolerance
- Cardiovascular Diseases
- Primary Dysautonomias
Interventions
- OTHER
-
Assessment of splanchnic capacitance
Splanchnic capacitance will be assessed using cpap and body impedance to construct pressure volume curves
- PROCEDURE
-
microneurography
microneurography will be measured in the peroneal nerve to assess sympathetic activity.
- DRUG
-
phenylephrine
Phenylephrine is a selective α1-adrenergic receptor agonist. It will be given in IV bolus injections starting from 12.5 ug. Incremental doses will be given every \~3 min up to 800 ug or until systolic blood pressure increases by 25 mmHg
- DRUG
-
isoproterenol
Isoproterenol is non-selective beta-adrenergic agonist. It will be given in IV bolus injections starting from 0.025 ug. Incremental doses will be given every \~3 min until heart rate increases by 25 bpm. This intervention is optional.
- RADIATION
-
25 micro-Ci of radiation
Using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation, blood samples are drawn before and 30 minutes after injection.
- PROCEDURE
-
Posture study with blood samples
Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume. An additional sample will be collected in the supine position for the autoantibody assessment.
- PROCEDURE
-
24-hour heart rhythm and blood pressure monitoring
Blood pressure, heart rate and ECG monitoring for 24 hours
- PROCEDURE
-
Quantitative Axonal Sudomotor Reflex Testing
The QSART assesses the ability of sympathetic nerve terminals in the skin to release acetylcholine and increase sweat production. The test is performed at 4 sites over the forearm, proximal lateral leg, medial distal leg and proximal foot.
- PROCEDURE
-
Autonomic function tests
The autonomic function tests will determine how well the autonomic nervous system regulates blood pressure and heart rate. These tests include breathing deeply for two minutes, breathing fast for 30 seconds, maintaining a handgrip for 3 minutes, breathing against pressure for 15 seconds, and placing the hand in ice water for 1 minute. In addition, participants will be tilted up on a tilt table for up to 10 minutes while recording their heart rate, blood pressure and cardiac output.
- OTHER
-
Rebreathing test
Cardiac output will be measured using the rebreathing technique (Innocor)
Sponsors & Collaborators
-
University of Oklahoma
collaborator OTHER -
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Luis Okamoto, MD · Vanderbilt University Medical Center
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2026-10-31
- Completion
- 2026-12-31
Countries
- United States
Study Locations
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