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

Mass General Brigham

Status: Active, not recruiting

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

Treatments: Other: Blood Sample Collection

Study type: Interventional

Funder types: Other

Identifiers

NCT07405515

2022A018462 (Other Grant/Funding Number)

2023P000633

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patients with Dysautonomia/POTS

Experimental group

Description:

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.

Treatment:

Other: Blood Sample Collection

Healthy Control Participants

Experimental group

Description:

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.

Treatment:

Other: Blood Sample Collection