RECRUITING

Autoimmune Basis for Postural Tachycardia Syndrome

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Conditions

Postural Tachycardia SyndromePOTSVagal StimulationAutoantibody

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Autoimmune Basis for Postural Tachycardia Syndrome

Quick Facts

Study Start:2022-01-14
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05043051

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-80 years old, female or male
  2. * 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
  3. * Able and willing to provide informed consent
  4. * Understand and be able to comply with the study procedures and restrictions
  1. * Hypertension (\>150 mmHg systolic and \>100 mmHg diastolic) based on history or findings at screening
  2. * Orthostatic hypotension (consistent drop in blood pressure \>20/10 mmHg with 10 min of standing)
  3. * Cardiovascular disease, such as myocardial infarction within 6 months
  4. * History or presence of significant immunological or hematological disorders
  5. * History of vagotomy
  6. * Currently pregnant women or women planning on becoming pregnant ≤ 3 months
  7. * Inability to comply with the protocol
  8. * Patients with active implants (such as a cardiac pacemaker, or a cochlear implant)

Contacts and Locations

Study Contact

Xichun Yu
CONTACT
405-271-5896
xichun-yu@ouhsc.edu
Brittany Karfonta
CONTACT
405-271-3480
Brittany-Karfonta@ouhsc.edu

Principal Investigator

Stavros Stavrakis, MD
STUDY_DIRECTOR
University of Oklahoma

Study Locations (Sites)

Oklahoma Clinical and Translational Science Institute
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Stavros Stavrakis, MD, STUDY_DIRECTOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-14
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2022-01-14
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • POTS
  • Vagal Stimulation
  • Autoantibody

Additional Relevant MeSH Terms

  • Postural Tachycardia Syndrome