POTSfBRINCT07405515
Pathophysiology of Dysautonomia and Postural Tachycardia Syndrome (POTS) in Post-viral Syndromes and COVID-19
A study testing Blood Sample Collection in people with POTS and POTS - Postural Orthostatic Tachycardia Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- POTS, POTS - Postural Orthostatic Tachycardia Syndrome, Dysautonomia
- What is being tested?
- Blood Sample Collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known causes of small fiber neuropathy, including: diabetes, amyloidosis, lupus, Sjogren syndrome, cancer, Ehlers-Danlos syndrome
- Other medical explanations for POTS symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- POTS, POTS - Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Autonomic Dysfunction
- Being tested
- Blood Sample Collection
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Autonomic Nervous System Diseases, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood Sample Collection |
| 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. Receives: Other: Blood Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single research visit per participant; outcomes assessed at the time of sample collection and analysis. Starting from 2024 and expected to end in 2027.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start2 Feb 2024
- Primary completion21 Jul 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for POTSStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- FBRI LLC (F-Prime Capital)
- Responsible party
- Principal investigator, Peter Novak, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405515
- Sponsor's protocol ID
- 2023P000633
- Other IDs
- 2022A018462
- Acronym
- fBRI
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology of Dysautonomia and Postural Tachycardia Syndrome (POTS) in Post-viral Syndromes and COVID-19
- ClinicalTrials.gov ID
- NCT07405515
- Acronym / sponsor ID
- fBRI / 2023P000633
- Conditions
- POTS, POTS - Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Autonomic Dysfunction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- FBRI LLC (F-Prime Capital)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Dysautonomia/POTS | Experimental | Other: Blood Sample CollectionParticipants 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. |
| Healthy Control Participants | Experimental | Other: Blood Sample CollectionHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Known causes of small fiber neuropathy, including: diabetes, amyloidosis, lupus, Sjogren syndrome, cancer, Ehlers-Danlos syndrome
- Other medical explanations for POTS symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionAll 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. | Other | Healthy Control Participants, Patients with Dysautonomia/POTS |
Primary outcome
Immune system profiling of peripheral blood: cytokines, immune cell populations, and inflammatory mediators
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Sample Collection in people with POTS and POTS - Postural Orthostatic Tachycardia Syndrome, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune system profiling of peripheral blood: cytokines, immune cell populations, and inflammatory mediators (time frame: Single research visit per participant; outcomes assessed at the time of sample collection and analysis. Starting from 2024 and expected to end in 2027.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.