Autoimmune Basis for Postural Tachycardia Syndrome

Postural Tachycardia Syndrome Clinical Trial

Official title:

Autoimmune Basis for Postural Tachycardia Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05043051
• Other study ID #: 13705
• Secondary ID: 2R01HL128393-04
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: University of Oklahoma
• Contact: Xichun Yu
• Phone: 405-271-5896
• Email: xichun-yu[@]ouhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Device:
• Vagal stimulation
Vagal stimulation
• Sham stimulation
Sham vagal stimulation

Locations

Country	Name	City	State
United States	Oklahoma Clinical and Translational Science Institute	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	Average of heart rate variability during the posture test	5 minute