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Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type
This study is ongoing, but not recruiting participants.
Study NCT00190411   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: September 13, 2005   Last Updated: March 13, 2007   History of Changes

September 13, 2005
March 13, 2007
October 2003
 
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
Same as current
Complete list of historical versions of study NCT00190411 on ClinicalTrials.gov Archive Site
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
Same as current
 
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.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
  • Ehlers-Danlos Syndrome, Type Iv, Autosomal Dominant
  • Gene Map Locus 2q31
Drug: celiprolol
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
October 2010
 

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.
Both
15 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00190411
 
AOM 01108, P010309
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