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临床试验/NCT04310644
NCT04310644招募中不适用

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)

RWTH Aachen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年9月15日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Maier

Primary Investigator and attending physician

RWTH Aachen University

研究点 (1)

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