Autoimmune Basis for Postural Tachycardia Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Heart rate variability
研究概览
简要总结
The purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (POTS). The investigators further hypothesize that electrical stimulation of the vagus nerve will improve POTS symptoms, autoimmunity and inflammation.
详细描述
The present study is designed to test the hypothesis that muscarinic autoantibody-mediated parasympathetic dysfunction contributes to the pathogenesis of POTS, and that parasympathetic (vagal) stimulation improves POTS symptoms, autoimmunity and inflammation.
Define and determine the prevalence, burden, and clinical significance of muscarinic autoantibodies in a well-phenotyped cohort of POTS patients with and without gastroparesis and a matched cohort of healthy control subjects.
Evaluate the impact of vagal stimulation on antibody suppression, inflammatory inhibition, and symptom improvement in POTS patients. Non-invasive transcutaneous stimulation of the auricular branch of the vagus nerve (tragus stimulation) will be used to increase parasympathetic activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-80 years old, female or male
- •Either healthy control or individual with postural tachycardia syndrome (POTS) defined as heart rate increase >30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (>20/10 mmHg fall in blood pressure), with chronic symptoms (>6 months), and in the absence of other acute cause of orthostatic tachycardia
- •Able and willing to provide informed consent
- •Understand and be able to comply with the study procedures and restrictions
排除标准
- •Hypertension (>150 mmHg systolic and >100 mmHg diastolic) based on history or findings at screening
- •Orthostatic hypotension (consistent drop in blood pressure >20/10 mmHg with 10 min of standing)
- •Cardiovascular disease, such as myocardial infarction within 6 months
- •History or presence of significant immunological or hematological disorders
- •History of vagotomy
- •Currently pregnant women or women planning on becoming pregnant ≤ 3 months
- •Inability to comply with the protocol
- •Patients with active implants (such as a cardiac pacemaker, or a cochlear implant)
- •Healthy control subjects will be healthy, non-smoking and on no chronic medications at the time of the study. Healthy control subjects will be group-matched to the POTS patients for age and gender.
研究组 & 干预措施
Vagal stimulation
Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.
干预措施: Vagal stimulation (Device)
Sham stimulation
Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.
干预措施: Sham stimulation (Device)
结局指标
主要结局
Heart rate variability
时间窗: 5 minute
Average of heart rate variability during the posture test
次要结局
未报告次要终点