Pathophysiology of Dysautonomia and Postural Tachycardia Syndrome (POTS) in Post-viral Syndromes … (NCT07405515) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pathophysiology of Dysautonomia and Postural Tachycardia Syndrome (POTS) in Post-viral Syndromes and COVID-19
United States100 participantsStarted 2024-02-02
Plain-language summary
This study aims to better understand the biological mechanisms underlying dysautonomia and postural orthostatic tachycardia syndrome (POTS), including how these conditions may be related to COVID-19. Participants will attend a single research visit lasting approximately one hour, during which a blood sample will be collected for immune system and genetic analyses. Information from participants' medical records may also be reviewed to support the research. The knowledge gained from this study may help improve understanding, diagnosis, and treatment of dysautonomia in the future.
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Female participants aged ≥18 years
* Diagnosis of idiopathic POTS (neuropathic form with evidence of neurodegeneration on skin biopsy) or Long COVID with or without POTS
* Age-matched healthy controls with normal autonomic testing
* Symptoms consistent with POTS: orthostatic intolerance ≥3 months with a clearly defined antecedent event (infection, travel, surgery)
* Orthostatic tachycardia \>30 BPM without orthostatic hypotension, associated with reduced cerebral orthostatic blood flow and hypocapnia
* Availability of electronic health record
Exclusion Criteria:
* Known causes of small fiber neuropathy, including: diabetes, amyloidosis, lupus, Sjogren syndrome, cancer, Ehlers-Danlos syndrome
* Other medical explanations for POTS symptoms
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Immune system profiling of peripheral blood: cytokines, immune cell populations, and inflammatory mediators
Timeframe: Single research visit per participant; outcomes assessed at the time of sample collection and analysis. Starting from 2024 and expected to end in 2027.