Pathophysiology of Dysautonomia and Postural Tachycardia Syndrome (POTS) in Post-viral Syndromes and COVID-19 (fBRI)

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 Overview

• Status: Active, not recruiting
• Conditions: Dysautonomia; Autonomic Dysfunction; POTS; POTS - Postural Orthostatic Tachycardia Syndrome
• Intervention / Treatment: Other: Blood Sample Collection

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Dysautonomia/POTS; 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.	Other: Blood 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.
Experimental: Healthy Control Participants; 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.	Other: Blood 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: FBRI LLC (F-Prime Capital)

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): July 21, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Orthostatic Intolerance; Autonomic Nervous System Diseases; Primary Dysautonomias; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: 2023P000633; 2022A018462 (Other Grant/Funding Number: FBRI LLC [Industry])

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No