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Autoimmune Basis for Postural Tachycardia Syndrome

Primary Purpose

Postural Tachycardia Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vagal stimulation
Sham stimulation
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postural Tachycardia Syndrome focused on measuring POTS, Vagal Stimulation, Autoantibody

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oklahoma Clinical and Translational Science InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Vagal stimulation

Sham stimulation

Arm Description

Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.

Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.

Outcomes

Primary Outcome Measures

Heart rate variability
Average of heart rate variability during the posture test

Secondary Outcome Measures

Full Information

First Posted
August 27, 2021
Last Updated
May 15, 2023
Sponsor
University of Oklahoma
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05043051
Brief Title
Autoimmune Basis for Postural Tachycardia Syndrome
Official Title
Autoimmune Basis for Postural Tachycardia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Tachycardia Syndrome
Keywords
POTS, Vagal Stimulation, Autoantibody

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vagal stimulation
Arm Type
Active Comparator
Arm Description
Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.
Intervention Type
Device
Intervention Name(s)
Vagal stimulation
Other Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
Vagal stimulation
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Other Intervention Name(s)
Transcutaneous electrical nerve stimulation
Intervention Description
Sham vagal stimulation
Primary Outcome Measure Information:
Title
Heart rate variability
Description
Average of heart rate variability during the posture test
Time Frame
5 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xichun Yu
Phone
405-271-5896
Ext
47779
Email
xichun-yu@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brittany Karfonta
Phone
405-271-3480
Ext
34889
Email
Brittany-Karfonta@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Stavrakis, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Study Director
Facility Information:
Facility Name
Oklahoma Clinical and Translational Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittany Karfonta
Phone
405-271-3480
Email
OSCTR@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Stavros Stavrakis, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Autoimmune Basis for Postural Tachycardia Syndrome

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