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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00190411
• Other study ID #: P010309
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: January 15, 2013
• Start date: October 2003
• Est. completion date: April 2011

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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.

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

Intervention

Drug:
• celiprolol
celiprolol
• Control
Untreated controls excluding betablockers

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Aventis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during de study	Yes
Secondary	Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.	Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.	during the study	Yes