Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190411
First received: September 13, 2005
Last updated: January 15, 2013
Last verified: March 2007

September 13, 2005
January 15, 2013
October 2003
April 2011   (final data collection date for primary outcome measure)
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
Complete list of historical versions of study NCT00190411 on ClinicalTrials.gov Archive Site
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
Not Provided
Not Provided
 
Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type
Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT
  • CHROMOSOME 2q31.2 DELETION SYNDROME
  • Drug: celiprolol
    celiprolol
    Other Names:
    • celiprolol
    • 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
Experimental: Treatment
Celiprolol
Interventions:
  • Drug: celiprolol
  • Drug: Control
Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. Epub 2010 Sep 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
15 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00190411
P010309
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Aventis Pharmaceuticals
Principal Investigator: Pierre BOUTOUYRIE, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP