ProANS
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)
Sponsor study identifier
observational
200
1 country
1
Study Start
September 15, 2019
Actual (reported)Primary Completion
September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2019
Actual (reported)March 13, 2020
Actual (reported)March 17, 2020
Actual (reported)September 15, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Blood pressure
Change in systolic and diastolic blood pressure over time
baseline, 3 months and 18 months
Heart frequency
Change in heart frequency over time
baseline, 3 months and 18 months
Skin biopsy
intraepithelial nerve fiber density between groups
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)
baseline, 3 months and 18 months
Patients with orthostatic intolerance because of Postural orthostatic tachycardia syndrome diagnosed in our outpatient clinic by tilt table examination.
Patients with hypermobile or classical EDS who are already diagnosed including genetical testing for classical or vascular EDS and Marfan Syndromes
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.
Healthy controls with no documented cardiovascular or neurological disorders and no symtoms of autonomic failure/dizziness/fainting
Patients are selected from clinical Routine and get our standart Treatment based on their disease
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
We will include patients with above mentioned disease who are diagnosed and treated in our outpatient clinic for autonomic disorders in Aachen, Germany.
University clinic RWTH Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Igharo D, Thiel JC, Rolke R, Akkaya M, Weis J, Katona I, Schulz JB, Maier A. Skin biopsy reveals generalized small fibre neuropathy in hypermobile Ehlers-Danlos syndromes. Eur J Neurol. 2023 Mar;30(3):719-728. doi: 10.1111/ene.15649. Epub 2022 Dec 13.
Gerlach DA, Maier A, Manuel J, Bach A, Hoff A, Honemann JN, Heusser K, Voit D, Frahm J, Jordan J, Tank J. Real-Time Magnetic Resonance Imaging to Study Orthostatic Intolerance Mechanisms in Human Beings: Proof of Concept. J Am Heart Assoc. 2022 Nov;11(21):e026437. doi: 10.1161/JAHA.122.026437. Epub 2022 Oct 27.
Andrea Maier
University Hospital, Aachen
First Submitted
March 13, 2020
First Posted
March 17, 2020
Study Start
September 15, 2019
Actual (reported)Primary Completion
September 15, 2028
EstimatedStanding Cognition and Co-morbidities of POTS Evaluation
Patients who have comorbidities as mast cell activation syndrome, chronic fatigue and/or Post COVID syndrome, based on clinical diagnosis in our outpatient clinic.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 15, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 4, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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