Autonomic Neuropathy and Its Pathophysiology in Autoimmune Autonomic Neuropathies, Postural Orthostatic Tachycardia Syndrome and Ehlers Danlos Syndromes: Peripheral Autonomic Small Fiber Neuropathy or Central Autonomic Failure? Validation of the Malmö POTS Score and a Better Diagnosis of POTS in Patientes With Autnomic Failure (VaGeMAPS-3-step-Diag)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
We examine patients with different autonomic neuropathies and Ehlers Danlos syndromes compared to healthy controls at three different points over time (baseline, after 3 months and after 1.5 years) to gain knowledge about the course of this disease and understand its pathophysiology, with a focus on Small Fiber neuropathy. Moreover we will validate the german version of the Malmö POTS Score and establish an easy diagnostic scheme for patients in outpatient care.
详细描述
Inclusion of patients with autoimmune autonomic neuropathies/ pure autonomic failure, postural orthostatic tachycardia syndrome, small fiber neuropathies, Ehlers-Danlos syndromes, Mast cell activation syndrom, Chronic fatigue syndrome and PostCOVID syndrome in our Registry study with follow up visits. Comparison to healthy controls concerning selected examinations.
Planned examinations are laboratory tests, questionnaires on mental and physical health status and circulatory disorders, attention tests, tilt table testing, standing test, sweat function, investigation of small fiber function via quantitative sensory testing as well as the density of nerve fibers in the skin. Measurements are performed at baseline mostly in clinical routine and follow up visits are offered.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 否
入选标准
- •autonomic neuropathy
- •Postural orthostatic tachycardia syndrome
- •hypermobile or classical Ehlers Danlos syndromes
- •Chronic fatigue syndrome, mast cell activation syndrome and/or PostCOVID
- •healty controls
- •between 18-80 years
- •in patients: diagnosis and clinical testing in our outpatient clinic
- •German speaking
排除标准
- •pregnancy
- •Pacemaker or Deep brain Stimulation
- •sensory or motor Polyneuropathy
- •neurodegenerative disease
结局指标
主要结局
Blood pressure
时间窗: baseline, 3 months and 18 months
Change in systolic and diastolic blood pressure over time
Skin biopsy
时间窗: baseline
intraepithelial nerve fiber density between groups
Heart frequency
时间窗: baseline, 3 months and 18 months
Change in heart frequency over time
Composite autonomic severity Score
时间窗: baseline, 3 months and 18 months
Change of the Score over time, the results are interpreted as normal (score=0), mild (score=1-3), moderate (score=4-6) or severe (score=7-10)
次要结局
未报告次要终点
研究者
Andrea Maier
Primary Investigator and attending physician
RWTH Aachen University
