An observational study in Autonomic Neuropathy, Ehlers-Danlos Syndrome Hypermobility Type and Small Fiber Neuropathy, sponsored by RWTH Aachen University. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by RWTH Aachen University · Observational
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.
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 200 is above the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →RWTH Aachen University is the lead sponsor of 228 studies on the registry; 19 are open to participants now.
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We will include patients with above mentioned disease who are diagnosed and treated in our outpatient clinic for autonomic disorders in Aachen, Germany.
Exclusion Criteria:
Patients with orthostatic intolerance because of Postural orthostatic tachycardia syndrome diagnosed in our outpatient clinic by tilt table examination.
Other: No intervention planned, but all patients get our standart treatment
Patients with hypermobile or classical EDS who are already diagnosed including genetical testing for classical or vascular EDS and Marfan Syndromes
Other: No intervention planned, but all patients get our standart treatment
Patients who have an autoimmune autonomic neuropathy based on clinical diagnosis and antibody testing in our outpatient clinic. Cardial MIBG Scintigraphy should have been performed.
Other: No intervention planned, but all patients get our standart treatment
Healthy controls with no documented cardiovascular or neurological disorders and no symtoms of autonomic failure/dizziness/fainting
Patients who have comorbidities as mast cell activation syndrome, chronic fatigue and/or Post COVID syndrome, based on clinical diagnosis in our outpatient clinic.
Patients are selected from clinical Routine and get our standart Treatment based on their disease
Blood pressure
Change in systolic and diastolic blood pressure over time
Time frame: baseline, 3 months and 18 months
Heart frequency
Change in heart frequency over time
Time frame: baseline, 3 months and 18 months
Skin biopsy
intraepithelial nerve fiber density between groups
Time frame: baseline
Composite autonomic severity Score
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)
Time frame: baseline, 3 months and 18 months
Plan to share: Undecided
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RWTH Aachen University