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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

Tracking Information
First Submitted Date  ICMJE August 27, 2021
First Posted Date  ICMJE September 13, 2021
Last Update Posted Date March 7, 2024
Actual Study Start Date  ICMJE January 14, 2022
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2021)		 Heart rate variability [ Time Frame: 5 minute ]
Average of heart rate variability during the posture test
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autoimmune Basis for Postural Tachycardia Syndrome
Official Title  ICMJE Autoimmune Basis for Postural Tachycardia Syndrome
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Postural Tachycardia Syndrome
Intervention  ICMJE
  • Device: Vagal stimulation
    Vagal stimulation
    Other Name: Transcutaneous electrical nerve stimulation
  • Device: Sham stimulation
    Sham vagal stimulation
    Other Name: Transcutaneous electrical nerve stimulation
Study Arms  ICMJE
  • 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.
    Intervention: Device: Vagal 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.
    Intervention: Device: Sham stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2021)		 80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2025
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xichun Yu 405-271-5896 ext 47779 xichun-yu@ouhsc.edu
Contact: Brittany Karfonta 405-271-3480 ext 34889 Brittany-Karfonta@ouhsc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05043051
Other Study ID Numbers  ICMJE 13705
2R01HL128393-04 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Oklahoma
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Oklahoma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Director: Stavros Stavrakis, MD University of Oklahoma
PRS Account University of Oklahoma
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP