Assessment of Antibodies and Inflammatory Markers in Postural Tachycardia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Ab titer in POTS patients compared to control subjects
研究概览
简要总结
In this pilot study, the investigators will test the hypothesis that patients with postural tachycardia syndrome will have an elevated percentage of functional antibodies to adrenergic receptors compared with control subjects without POTS. The investigators further hypothesize that the percentage of POTS patients with antibodies will be higher in those patients with a viral infection at the onset of their illness than in those patients with other or undefined illness onsets.
详细描述
Postural orthostatic tachycardia syndrome is poorly understood. Many of these patients have elevated levels of plasma norepinephrine, particularly when upright One subgroup of patients has a primary hyperadrenergic state. The majority of patients have a marked deficit in plasma blood volume compared to healthy control subjects. The investigators have previously reported that some patients suffer paradoxically from a partial dysautonomia affecting the lower limbs. Most patients seem to suffer from either a primary or secondary increase in central sympathetic nervous system drive. Recent data have shown that patients with postural orthostatic tachycardia syndrome have a lower cardiac stroke volume than their healthy counterparts and this low stroke volume may drive their orthostatic tachycardia.
The investigators plan to do the following:
The physical examination will include (at minimum):
- Height
- Weight
- Orthostatic vital signs (heart rate and blood pressure) Supine and Standing for up to 10 minutes
- Beighton Criteria for Joint Hypermobility Syndrome (Ehlers-Danlos III)
- Dependent acrocyanosis (during stand test)
Continuous Heart Rate and Blood Pressure Recording A subset of subjects will be given the opportunity to also have continuous recordings of heart rate and blood pressure for 5-10 minutes while lying down quietly. They will be instrumented with EKG patches on their body and a finger blood pressure cuff, and these data will be digitally sampled and acquired on a dedicated laptop computer for later offline analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Postural Tachycardia Syndrome
- •Previously diagnosed with POTS
- •Control Subjects
- •Not diagnosed with POTS
- •Age between 13-80 years
- •Male and female subjects are eligible.
- •Able and willing to provide informed consent
排除标准
- •Inability to give, or withdrawal of, informed consent
- •Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
结局指标
主要结局
Ab titer in POTS patients compared to control subjects
时间窗: One time only, at first visit
The primary outcome measure will be the proportion of subjects with alpha-1 Ab titer. The primary comparison will be the proportion of Ab titers between POTS patients compared to control subjects.
次要结局
- comparison of the number of POTS patients with fatigue versus no history of fatigue based on severity of impact on normal daily activities.(One time only - at first study visit)
- comparison of the number of POTS patients with and without Ehlers Danlos syndrome III(One time only - at first study visit)
- comparison of the number of POTS patients with a history of autoimmune disorders versus no history of auto-immune disorders(One time only - at first study visit)
- comparison of pain in POTS patients versus non-POTS patients(One time only - at first study visit)
- comparison of the number of POTS patients with viral based Ab versus non-viral based Ab(One time only - at first study visit)
研究者
Satish R. Raj
Adjunct Associate Professor of Medicine and Pharmacology
Vanderbilt University