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NCT04310644 Clinical Trial

Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry

Postural Tachycardia Syndrome Clinical Trial

— ProANS  

Official title:
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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04310644
Other study ID # 19-016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2019
Est. completion date September 15, 2029

Study information
Verified date June 2023
Source RWTH Aachen University
Contact Andrea Maier, physician
Phone +492418089600
Email ans-ambulanz@ukaachen.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date September 15, 2029
Est. primary completion date September 15, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - pregnancy - Pacemaker or Deep brain Stimulation - sensory or motor Polyneuropathy - neurodegenerative disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention planned, but all patients get our standart treatment
Patients are selected from clinical Routine and get our standart Treatment based on their disease

Locations
Country Name City State
Germany University clinic RWTH Aachen Aachen Nordrhein Westfalen

Sponsors (2)
Lead Sponsor Collaborator
RWTH Aachen University DLR German Aerospace Center

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood pressure Change in systolic and diastolic blood pressure over time baseline, 3 months and 18 months
Primary Heart frequency Change in heart frequency over time baseline, 3 months and 18 months
Primary Skin biopsy intraepithelial nerve fiber density between groups baseline
Primary 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
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Active, not recruiting NCT05630040 - VNS for Long-COVID-19 N/A
Recruiting NCT04632134 - Long-term Effects of Transcutaneous Vagal Nerve Stimulation on Postural Orthostatic Tachycardia Syndrome (POTS) N/A
Completed NCT00685919 - Peripheral Dopamine in Postural Tachycardia Syndrome Phase 2/Phase 3
Completed NCT00061009 - Hypnosis in Autonomic Function N/A
Recruiting NCT05618054 - Periaqueductal Gray-vagus Nerve Interface Malfunction Explain the Natural History With Its Numerous Co-morbidities? N/A
Completed NCT01366963 - Cognitive Dysfunction in Postural Tachycardia Syndrome N/A
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Terminated NCT02154009 - Clinical Autonomic Disorders: A Training Protocol
Completed NCT03602482 - Standing Cognition and Co-morbidities of POTS Evaluation N/A
Completed NCT02167412 - EEG Characteristics in Youth POTS and/or Syncope
Active, not recruiting NCT00692471 - Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

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