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NCT04310644: ProANS

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

Recruiting now Last updated 4 February 2025
What this trial tests

trial testing No intervention planned, but all patients get our standart treatment in Autonomic Neuropathy in 200 participants. Currently enrolling.

Timeline
15 September 2019
Primary endpoint
15 September 2028
15 September 2029

Quick facts

Lead sponsorRWTH Aachen University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment200
Start date15 September 2019
Primary completion15 September 2028
Estimated completion15 September 2029
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

RWTH Aachen University

Who can join

Adults 18 to 80, any sex, with Autonomic Neuropathy or Ehlers-Danlos Syndrome Hypermobility Type. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Deep abdominal breathing reduces heart rate and symptoms during orthostatic challenge in patients with postural orthostatic tachycardia syndrome.
    Stick M, Leone A, Fischer F, Schulz JB, et al · · 2024 · cited 2× · PMID 38962840 · DOI 10.1111/ene.16402
  2. Real-Time Magnetic Resonance Imaging to Study Orthostatic Intolerance Mechanisms in Human Beings: Proof of Concept.
    Gerlach DA, Maier A, Manuel J, Bach A, et al · · 2022 · cited 1× · PMID 36300662 · DOI 10.1161/jaha.122.026437

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