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Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

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ClinicalTrials.gov Identifier: NCT00190411
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 16, 2013
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT CHROMOSOME 2q31.2 DELETION SYNDROME Drug: celiprolol Drug: Control Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome
Study Start Date : October 2003
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Celiprolol
 Drug: celiprolol
celiprolol
Other Names:
  • celiprolol? Dose ranging 100 to 400 mg, dose adaptation
  • every 6 months by increment of 100 mg, based on tolerance

Drug: Control
Untreated controls excluding betablockers


Outcome Measures
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Primary Outcome Measures :
  1. reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up [ Time Frame: during de study ]
    reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up


Secondary Outcome Measures :
  1. Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness. [ Time Frame: during the study ]
    Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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 CELIPROLOL:
  • 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 CELIPROLOL
  • Antecedent of anaphylactic reaction
  • myasthenia
  • treatment by FLOCTAFENINE ( 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
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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): NCT00190411


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Aventis Pharmaceuticals
Investigators
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Principal Investigator: Pierre BOUTOUYRIE, MD,PhD Assistance Publique - Hôpitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190411    
Other Study ID Numbers: P010309
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: March 2007
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Arteries
ultrasonography
Ehlers Danlos syndrome
Cardiovascular disease
beta adrenergic antagonists
Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome, Type IV
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
 Connective Tissue Diseases
Skin Diseases
Aortic Dissection
Dissection, Blood Vessel
Aneurysm
Celiprolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists