Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

March 13, 2007

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00190411 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

Official Title ^ICMJE

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 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Ehlers-Danlos Syndrome, Type Iv, Autosomal Dominant
Gene Map Locus 2q31

Intervention ^ICMJE

Drug: celiprolol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

100

Completion Date

October 2010

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

15 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00190411

Responsible Party

Study ID Numbers ^ICMJE

AOM 01108, P010309

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Aventis Pharmaceuticals

Investigators ^ICMJE

Principal Investigator:

Pierre BOUTOUYRIE, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP