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

NCT07405515 | Active Not Recruiting

• 2 other identifiers: 2023P0006332022A018462
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

POTS; POTS - Postural Orthostatic Tachycardia Syndrome; Dysautonomia; Autonomic Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

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.

Other: Blood Sample Collection

Interventions

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.

Healthy Control Participants; Patients with Dysautonomia/POTS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known causes of small fiber neuropathy, including: diabetes, amyloidosis, lupus, Sjogren syndrome, cancer, Ehlers-Danlos syndrome
• Other medical explanations for POTS symptoms

Sponsors & Collaborators

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

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Autonomic Nervous System Diseases; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 12, 2026
• Study Start: February 2, 2024
• Primary Completion: July 21, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)