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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorRWTH Aachen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

autonomic neuropathy

Postural orthostatic tachycardia syndrome

hypermobile or classical Ehlers Danlos syndromes

Chronic fatigue syndrome, mast cell activation syndrome and/or PostCOVID

Disqualifiers

pregnancy

Pacemaker or Deep brain Stimulation

sensory or motor Polyneuropathy

neurodegenerative disease

Trial population

We will include patients with above mentioned disease who are diagnosed and treated in our outpatient clinic for autonomic disorders in Aachen, Germany.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • No intervention planned, but all patients get our standart treatment

    Other intervention

    Patients are selected from clinical Routine and get our standart Treatment based on their disease

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: Postural Orthostatic Tachycardia Syndrome1 intervention
Group B: Ehlers Danlos Syndrome1 intervention
Group C: Autoimmune autonomic neuropathy/Pure autonomic failure1 intervention
Group D: Healthy controls0 interventions
Group E: others0 interventions

Trial outcomes

Primary outcomes

1

Blood pressure

Change in systolic and diastolic blood pressure over time

Time frame
baseline, 3 months and 18 months
2

Heart frequency

Change in heart frequency over time

Time frame
baseline, 3 months and 18 months
3

Skin biopsy

intraepithelial nerve fiber density between groups

Time frame
baseline
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RWTH Aachen University

Lead sponsor

DLR German Aerospace Center

Collaborator