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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Autonomic Neuropathy Ehlers-Danlos Syndrome Hypermobility Type Small Fiber Neuropathy Postural Tachycardia Syndrome Other: No intervention planned, but all patients get our standart treatment

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
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?
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : September 15, 2024
Estimated Study Completion Date : September 15, 2029


Group/Cohort Intervention/treatment
Postural Orthostatic Tachycardia Syndrome
Patients with orthostatic intolerance because of Postural orthostatic tachycardia syndrome diagnosed in our outpatient clinic by tilt table examination.
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

Ehlers Danlos Syndrome
Patients with hypermobile or classical EDS who are already diagnosed including genetical testing for classical or vascular EDS and Marfan Syndromes
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

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.
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

Healthy controls
Healthy controls with no documented cardiovascular or neurological disorders and no symtoms of autonomic failure/dizziness/fainting



Primary Outcome Measures :
  1. Blood pressure [ Time Frame: baseline, 3 months and 18 months ]
    Change in systolic and diastolic blood pressure over time

  2. Heart frequency [ Time Frame: baseline, 3 months and 18 months ]
    Change in heart frequency over time

  3. Skin biopsy [ Time Frame: baseline ]
    intraepithelial nerve fiber density between groups

  4. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310644


Contacts
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Contact: Andrea Maier, physician +492418089600 ext +492418089600 ans-ambulanz@ukaachen.de
Contact: Denver Igharo, student +492418089600 ext +492418089600 ans-ambulanz@ukaachen.de

Locations
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Germany
University clinic RWTH Aachen Recruiting
Aachen, Nordrhein Westfalen, Germany, 52074
Contact: Andrea Maier, physician    +492418089600 ext +492418089600    ans-ambulanz@ukaachen.de   
Contact: Denver Igharo, student    +492418089600 ext +492418089600    ans-ambulanz@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
DLR German Aerospace Center
Investigators
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Principal Investigator: Andrea Maier University Hospital, Aachen
Additional Information:
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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT04310644    
Other Study ID Numbers: 19-016
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Postural Orthostatic Tachycardia Syndrome
Small Fiber Neuropathy
Tachycardia
Ehlers-Danlos Syndrome
Syndrome
Nervous System Diseases
Disease
Pathologic Processes
Neuromuscular Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Hemostatic Disorders
Vascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases