Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

CHROMOSOME 2q31.2 DELETION SYNDROME Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormalities, Multiple
• CHROMOSOME 2q31.2 DELETION SYNDROME
• Chromosome Deletion
• Craniofacial Abnormalities
• Ehlers-Danlos Syndrome
• EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT
• Intellectual Disability
• Syndrome

• NCT number: NCT00190411
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: Phase 4
• Start date: October 2003
• Completion date: April 2011