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| ID | Type | Description | Link |
|---|---|---|---|
| 2022A018462 | Other Grant/Funding Number | FBRI LLC [Industry] |
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| Name | Class |
|---|---|
| FBRI LLC (F-Prime Capital) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Dysautonomia/POTS | Experimental | Participants with a diagnosis of dysautonomia or POTS will undergo a single blood draw of approximately 30 mL for research purposes, including immune system and genetic analyses. Samples will be coded and stored for future research. No therapeutic intervention is administered. |
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| Healthy Control Participants | Experimental | Healthy volunteers without dysautonomia or POTS will undergo the same single blood draw of approximately 30 mL for research purposes, including immune system and genetic analyses. Samples will be coded and stored for future research. No therapeutic intervention is administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Sample Collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune system profiling of peripheral blood: cytokines, immune cell populations, and inflammatory mediators | 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. | Single research visit per participant; outcomes assessed at the time of sample collection and analysis. Starting from 2024 and expected to end in 2027. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
The study will not share individual participant data due to privacy concerns and the sensitive nature of genetic and immune system information. Data will be de-identified and stored securely, and only aggregate results will be shared in publications.
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| D001342 | Autonomic Nervous System Diseases |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D009422 | Nervous System Diseases |
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