Autonomic Dysfunction, Dysautonomia, POTS, POTS - Postural Orthostatic Tachycardia Syndrome
Conditions
Brief 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.
Interventions
OTHERBlood Sample Collection
All participants, including people diagnosed with dysautonomia/POTS and healthy control participants, will undergo a single blood draw of approximately 30 mL (about 2 tablespoons). The blood will be collected for research purposes, including immune system and genetic analyses, and stored in a coded fashion for future research. No therapeutic intervention, drug, or device will be administered.
Sponsors
Brigham and Women's Hospital
FBRI LLC (F-Prime Capital)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immune system profiling of peripheral blood: cytokines, immune cell populations, and inflammatory mediators | Single research visit per participant; outcomes assessed at the time of sample collection and analysis. Starting from 2024 and expected to end in 2027. | Peripheral blood will be collected from participants with POTS/dysautonomia, Long COVID, and healthy controls during a single research visit (\~1 hour). Samples will be analyzed to quantify cytokines, immune cell subsets, and inflammatory mediators to identify immune signatures associated with dysautonomia and PASC. Data will be aggregated by participant group and analyzed for differences in immune profiles. |
Countries
United States
Outcome results
None listed