Autoimmune Basis for Postural Tachycardia Syndrome
United States80 participantsStarted 2022-01-14
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was studying whether POTS has an autoimmune basis by measuring heart rate variability — has any data or findings from this completed study been published yet, and could it change how my POTS might be evaluated or treated?
2Since this trial was focused on understanding the autoimmune mechanisms behind POTS rather than testing a new treatment, does it suggest I should be tested for autoimmune markers or antibodies as part of my own workup?
3Heart rate variability was the primary outcome being measured — is that something you already track in my care, and could it tell us anything useful about how my autonomic nervous system is functioning?
4Given that this study has completed and was investigating a potential autoimmune cause of POTS, do you think my case fits a profile where an autoimmune-focused treatment approach might be worth exploring?
5Are there any follow-up studies or trials building on this autoimmune research that I might be a candidate to discuss with you, now that this particular study is finished?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.