Clinical Trial: Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: 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


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

Current Secondary Outcome: 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.


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

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: September 13, 2005
Date Started: October 2003
Date Completion:
Last Updated: January 15, 2013
Last Verified: March 2007