Investigating the autoimmune causes of Postural Tachycardia Syndrome and the effects of vagal stimulation
Autoimmune Basis for Postural Tachycardia Syndrome
This study is testing if certain autoimmune factors cause Postural Tachycardia Syndrome (POTS) and whether using vagal nerve stimulation can help relieve symptoms for people with this condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05043051 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the role of muscarinic autoantibodies in the development of Postural Tachycardia Syndrome (POTS) and assess whether vagal nerve stimulation can alleviate symptoms associated with this condition. Researchers will evaluate a cohort of POTS patients and healthy controls to determine the prevalence of these autoantibodies and their impact on autonomic function. The study will utilize non-invasive transcutaneous vagal stimulation to enhance parasympathetic activity and potentially reduce inflammation and improve symptoms in participants. The findings could provide insights into the autoimmune mechanisms underlying POTS and offer a novel therapeutic approach.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-80 diagnosed with Postural Tachycardia Syndrome or healthy controls without significant cardiovascular issues.
Not a fit: Patients with hypertension, orthostatic hypotension, or significant cardiovascular or immunological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from POTS by targeting autoimmune mechanisms.
How similar studies have performed: While the specific approach of vagal stimulation in POTS is novel, there is emerging evidence supporting the role of autoimmunity in similar conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oklahoma City, Oklahoma
- Oklahoma Clinical and Translational Science Institute — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Study coordinator: Xichun Yu
- Email: xichun-yu@ouhsc.edu
- Phone: 405-271-5896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.