Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Collaborator: Aventis Pharmaceuticals

Source Assistance Publique - Hôpitaux de Paris
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

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.

Overall Status Completed
Start Date 2003-10-01
Completion Date 2011-04-01
Primary Completion Date 2011-04-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up during de study
Secondary Outcome
Measure Time Frame
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness. during the study
Enrollment 54
Condition
Intervention

Intervention Type: Drug

Intervention Name: celiprolol

Description: celiprolol

Arm Group Label: Treatment

Intervention Type: Drug

Intervention Name: Control

Description: Untreated controls excluding betablockers

Arm Group Label: Treatment

Eligibility

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.

Gender:

All

Minimum Age:

15 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Pierre BOUTOUYRIE, MD,PhD Principal Investigator Assistance Publique - Hôpitaux de Paris
Verification Date

2007-03-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Treatment

Type: Experimental

Description: Celiprolol

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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