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

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ClinicalTrials.gov Identifier: NCT04310644
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
DLR German Aerospace Center
Information provided by (Responsible Party):
RWTH Aachen University

Tracking Information
First Submitted Date March 13, 2020
First Posted Date March 17, 2020
Last Update Posted Date March 17, 2020
Actual Study Start Date September 15, 2019
Estimated Primary Completion Date September 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2020)
  • Blood pressure [ Time Frame: baseline, 3 months and 18 months ]
    Change in systolic and diastolic blood pressure over time
  • Heart frequency [ Time Frame: baseline, 3 months and 18 months ]
    Change in heart frequency over time
  • Skin biopsy [ Time Frame: baseline ]
    intraepithelial nerve fiber density between groups
  • Composite autonomic severity Score [ Time Frame: baseline, 3 months and 18 months ]
    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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Autonomic Small Fiber Neuropathy and Ehlers Danlos Syndromes - Prospective Study and Registry
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?
Brief 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.
Detailed Description

Inclusion of patients with autoimmune autonomic neuropathies/ pure autonomic failure, postural orthostatic tachycardia syndrome, small fiber neuropathies and Ehlers Danlos syndromes in our Register study with follow up visits. Comparison to healthy controls.

Planned examinations are laboratory tests, questionnaires on mental and physical health status and circulatory disorders, attention tests, tilt table testing, 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population We will include patients with above mentioned disease who are diagnosed and treated in our outpatient clinic for autonomic disorders in Aachen, Germany.
Condition
  • Autonomic Neuropathy
  • Ehlers-Danlos Syndrome Hypermobility Type
  • Small Fiber Neuropathy
  • Postural Tachycardia Syndrome
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
Study Groups/Cohorts
  • Postural Orthostatic Tachycardia Syndrome
    Patients with orthostatic intolerance because of Postural orthostatic tachycardia syndrome diagnosed in our outpatient clinic by tilt table examination.
    Intervention: Other: No intervention planned, but all patients get our standart treatment
  • Ehlers Danlos Syndrome
    Patients with hypermobile or classical EDS who are already diagnosed including genetical testing for classical or vascular EDS and Marfan Syndromes
    Intervention: Other: No intervention planned, but all patients get our standart treatment
  • Autoimmune autonomic neuropathy/Pure autonomic failure
    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.
    Intervention: Other: No intervention planned, but all patients get our standart treatment
  • Healthy controls
    Healthy controls with no documented cardiovascular or neurological disorders and no symtoms of autonomic failure/dizziness/fainting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 13, 2020)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 15, 2029
Estimated Primary Completion Date September 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • autonomic neuropathy
  • Postural orthostatic tachycardia syndrome
  • hypermobile or classical Ehlers Danlos syndromes
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Andrea Maier, physician +492418089600 ext +492418089600 ans-ambulanz@ukaachen.de
Contact: Denver Igharo, student +492418089600 ext +492418089600 ans-ambulanz@ukaachen.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04310644
Other Study ID Numbers 19-016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party RWTH Aachen University
Study Sponsor RWTH Aachen University
Collaborators DLR German Aerospace Center
Investigators
Principal Investigator: Andrea Maier University Hospital, Aachen
PRS Account RWTH Aachen University
Verification Date March 2020