Observing autonomic neuropathies and Ehlers Danlos syndromes over time
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)
Run by RWTH Aachen University · NCT04310644 · Data updated 2026-11-12
This study is trying to understand how autonomic neuropathies and Ehlers Danlos syndromes change over time in patients compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | RWTH Aachen University Academic / other |
| Locations | 1 site (Aachen, North Rhine-Westphalia) |
| Status | Recruiting |
| Started | September 15, 2019 |
| Main results expected | September 15, 2028 |
| Study ends | September 15, 2029 |
| Registry record updated | February 4, 2025 |
| Trial ID | NCT04310644 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18-80 with autonomic neuropathy, postural orthostatic tachycardia syndrome, hypermobile or classical Ehlers Danlos syndromes, chronic fatigue syndrome, mast cell activation syndrome, or PostCOVID syndrome.
✕Probably not a fit
Patients with pregnancy, pacemakers, deep brain stimulation, sensory or motor polyneuropathy, or neurodegenerative diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines patients with various autonomic neuropathies and Ehlers Danlos syndromes, comparing them to healthy controls at three different time points: baseline, after 3 months, and after 1.5 years. The goal is to gain insights into the progression of these conditions and their underlying mechanisms, particularly focusing on small fiber neuropathy. Participants will undergo a series of assessments, including laboratory tests, questionnaires, and specialized tests to evaluate their health status and nerve function. The study also aims to validate a German version of the Malmö POTS Score and create a straightforward diagnostic scheme for outpatient care.
Why it matters
Potential benefit: If successful, this study could enhance understanding and management of autonomic neuropathies and Ehlers Danlos syndromes, leading to better patient outcomes.
How similar studies have gone: While this study builds on existing knowledge, the specific combination of conditions and the proposed methodology may offer novel insights into these syndromes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University clinic RWTH Aachen
Aachen, North Rhine-Westphalia, Germany Recruiting
Study contacts
- Principal investigator: Andrea Maier — University Hospital, Aachen
- Study coordinator: Andrea Maier, physician
- Email: ans-ambulanz@ukaachen.de
- Phone: +492418089600
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.