Autoimmune Basis for Postural Tachycardia Syndrome

Last updated: March 24, 2025
Sponsor: University of Oklahoma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysrhythmia

Heart Disease

Heart Defect

Treatment

Vagal stimulation

Sham stimulation

Clinical Study ID

NCT05043051
13705
2R01HL128393-04
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 theabsence of orthostatic hypotension (>20/10 mmHg fall in blood pressure), withchronic symptoms (>6 months), and in the absence of other acute cause of orthostatictachycardia

  • Able and willing to provide informed consent

  • Understand and be able to comply with the study procedures and restrictions

Exclusion

Exclusion Criteria:

  • Hypertension (>150 mmHg systolic and >100 mmHg diastolic) based on history orfindings at screening

  • Orthostatic hypotension (consistent drop in blood pressure >20/10 mmHg with 10 minof 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.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Vagal stimulation
Phase:
Study Start date:
January 14, 2022
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Oklahoma Clinical and Translational Science Institute

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.