Pathophysiology of Dysautonomia and Postural Tachycardia Syndrome (POTS) in Post-viral Syndromes and COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Immune system profiling of peripheral blood: cytokines, immune cell populations, and inflammatory mediators
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Known causes of small fiber neuropathy, including: diabetes, amyloidosis, lupus, Sjogren syndrome, cancer, Ehlers-Danlos syndrome
- •Other medical explanations for POTS symptoms
研究组 & 干预措施
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.
干预措施: Blood Sample Collection (Other)
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.
干预措施: Blood Sample Collection (Other)
结局指标
主要结局
Immune system profiling of peripheral blood: cytokines, immune cell populations, and inflammatory mediators
时间窗: 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.
次要结局
未报告次要终点
研究者
Peter Novak
MD, PhD
Brigham and Women's Hospital