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Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Assistance Publique - Hôpitaux de Paris
Aventis Pharmaceuticals
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190411
  Purpose

Ehlers-Danlos syndrome vascular type (EDS-IV) is caused by a genetic defect of collagen type III. Patient die (median 40 yrs) of vascular complications. There is no treatment. We showed that arteries are thin and overloaded in this patients. We test the protective effect of celiprolol on cardiovascular events in a 5 years, randomized, PROBE design


Condition Intervention Phase
Ehlers-Danlos Syndrome, Type Iv, Autosomal Dominant
Gene Map Locus 2q31
Drug: celiprolol
Phase III

Genetics Home Reference related topics:   Ehlers-Danlos syndrome    hemophilia   

MedlinePlus related topics:   Ehlers-Danlos Syndrome   

ChemIDplus related topics:   Celiprolol    Celiprolol hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up

Secondary Outcome Measures:
  • Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.

Estimated Enrollment:   100
Study Start Date:   October 2003
Estimated Study Completion Date:   October 2010

Detailed Description:

100 patients with verified EDS-IV syndrome are included. Patients are randomized to either celiprolol (50 to 400 mg BID)or no treatment. Patients who are not randomized enter a longitudinal survey of events. The hypothesis is a 50% reduction in the occurrence of cardiovascular events under treatment, assessed by a blinded, independent events committee.

  Eligibility
Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Proven disease,
  • No betablocker at inclusion if previous CV event

Exclusion criteria:

Criteria of not inclusion for the RIGHTEOUS group:

  • Patient having already presented an arterial break or a dissection and treated(handled) by bétâ-blocking(surrounding).
  • Against indication in the use of Céliprolol:
  • Unchecked cardiac insufficiency by the treatment
  • cardiogenic shock
  • BAV of 2nd and 3rd not sailed degrees
  • angor of Prinzmetal
  • disease of the sine
  • bradycardia
  • pheochromocytoma untreated
  • low blood pressure
  • sentimentality in the céliprolol
  • Antecedent of anaphylactic reaction
  • myasthenia
  • treatment by Floctafénine ( Idarac), Sultopride ( interactions ) In these two cases, the patient can be included in the group followed by troop.

Criteria of not inclusion for both groups:

  • Refusal to participate in the study.
  • Impossibility to move.
  • Pregnancy
  • Woman in age to procreate without means of effective contraception.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190411

Locations
France
Clinical Pharmacology Unit, HEGP, AP-HP    
      Paris, France, 75015

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Aventis Pharmaceuticals

Investigators
Principal Investigator:     Pierre BOUTOUYRIE, MD,PhD     Assistance Publique - Hôpitaux de Paris    
  More Information

Study ID Numbers:   AOM 01108, P010309
First Received:   September 13, 2005
Last Updated:   March 13, 2007
ClinicalTrials.gov Identifier:   NCT00190411
Health Authority:   France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Arteries  
ultrasonography  
Ehlers Danlos syndrome  
Cardiovascular disease  
beta adrenergic antagonists  

Study placed in the following topic categories:
Ehlers-Danlos Syndrome
Celiprolol
Skin Diseases
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Skin Abnormalities
Hemostatic Disorders
Ehlers-Danlos syndrome
Hemorrhagic Disorders
Genetic Diseases, Inborn
Connective Tissue Diseases
Ehlers Danlos syndrome type 4, autosomal dominant
Congenital Abnormalities
Skin Diseases, Genetic

Additional relevant MeSH terms:
Vasodilator Agents
Sympatholytics
Neurotransmitter Agents
Disease
Collagen Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Syndrome
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on September 05, 2008




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