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Autoimmune Basis for Postural Tachycardia Syndrome

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ClinicalTrials.gov Identifier: NCT05043051
Recruitment Status : Recruiting
First Posted : September 13, 2021
Last Update Posted : March 7, 2024
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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Brief Summary:
The purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (POTS). The investigators further hypothesize that electrical stimulation of the vagus nerve will improve POTS symptoms, autoimmunity and inflammation.

Condition or disease Intervention/treatment Phase
Postural Tachycardia Syndrome Device: Vagal stimulation Device: Sham stimulation Not Applicable

Detailed Description:

The present study is designed to test the hypothesis that muscarinic autoantibody-mediated parasympathetic dysfunction contributes to the pathogenesis of POTS, and that parasympathetic (vagal) stimulation improves POTS symptoms, autoimmunity and inflammation.

Define and determine the prevalence, burden, and clinical significance of muscarinic autoantibodies in a well-phenotyped cohort of POTS patients with and without gastroparesis and a matched cohort of healthy control subjects.

Evaluate the impact of vagal stimulation on antibody suppression, inflammatory inhibition, and symptom improvement in POTS patients. Non-invasive transcutaneous stimulation of the auricular branch of the vagus nerve (tragus stimulation) will be used to increase parasympathetic activity.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Autoimmune Basis for Postural Tachycardia Syndrome
Actual Study Start Date : January 14, 2022
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : July 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Vagal stimulation
Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.
 Device: Vagal stimulation
Vagal stimulation
Other Name: Transcutaneous electrical nerve stimulation
Sham Comparator: Sham stimulation
Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.
 Device: Sham stimulation
Sham vagal stimulation
Other Name: Transcutaneous electrical nerve stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: 5 minute ]
    Average of heart rate variability during the posture test


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-80 years old, female or male
  • Either healthy control or individual with postural tachycardia syndrome (POTS) defined as 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
  • Understand and be able to comply with the study procedures and restrictions

Exclusion Criteria:

  • 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 of standing)
  • Cardiovascular disease, such as myocardial infarction within 6 months
  • History or presence of significant immunological or hematological disorders
  • History of vagotomy
  • Currently pregnant women or women planning on becoming pregnant ≤ 3 months
  • Inability to comply with the protocol
  • Patients with active implants (such as a cardiac pacemaker, or a cochlear implant)

Healthy control subjects will be healthy, non-smoking and on no chronic medications at the time of the study. Healthy control subjects will be group-matched to the POTS patients for age and gender.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043051


Contacts
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Contact: Xichun Yu 405-271-5896 ext 47779 xichun-yu@ouhsc.edu
Contact: Brittany Karfonta 405-271-3480 ext 34889 Brittany-Karfonta@ouhsc.edu

Locations
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United States, Oklahoma
Oklahoma Clinical and Translational Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Brittany Karfonta    405-271-3480    OSCTR@ouhsc.edu   
Principal Investigator: Stavros Stavrakis, MD         
Sponsors and Collaborators
University of Oklahoma
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Study Director: Stavros Stavrakis, MD University of Oklahoma
More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT05043051    
Other Study ID Numbers: 13705
2R01HL128393-04 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: March 7, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Oklahoma:
POTS
Vagal Stimulation
Autoantibody
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases