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Search / Trial NCT05043051

Autoimmune Basis for Postural Tachycardia Syndrome

Launched by UNIVERSITY OF OKLAHOMA · Sep 8, 2021

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Pots Vagal Stimulation Autoantibody

ClinConnect Summary

This clinical trial is investigating the role of the immune system in causing symptoms of Postural Tachycardia Syndrome (POTS), a condition where patients experience a significant increase in heart rate when standing up. Researchers believe that an autoimmune reaction—where the body’s immune system mistakenly attacks its own tissues—may be linked to these symptoms. They also want to see if stimulating the vagus nerve, which helps regulate heart and digestive functions, can improve symptoms related to POTS and reduce inflammation.

To participate in this study, individuals must be between 18 and 80 years old and can either be healthy or diagnosed with POTS. Key criteria for POTS patients include having a heart rate increase of more than 30 beats per minute when standing, along with ongoing symptoms for at least six months. Participants will be carefully screened to ensure they don’t have certain conditions, like high blood pressure or heart disease. Those who join the study will receive a thorough explanation of the procedures and what to expect throughout the trial, helping them understand their role in advancing research on POTS.

Gender

ALL

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.

About University Of Oklahoma

The University of Oklahoma, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a robust network of interdisciplinary experts and state-of-the-art facilities, the university fosters an environment that promotes scientific discovery and the development of new treatments. Its commitment to patient-centered research ensures that clinical trials not only adhere to the highest ethical standards but also aim to address pressing health challenges. By collaborating with various stakeholders, including industry partners and healthcare providers, the University of Oklahoma seeks to translate research findings into tangible benefits for communities, ultimately enhancing the quality of care and improving health outcomes.

Locations

Oklahoma City, Oklahoma, United States

Patients applied

0 patients applied

Trial Officials

Stavros Stavrakis, MD

Study Director

University of Oklahoma

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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