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

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Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

This study is ongoing, but not recruiting participants.

Study NCT00190411. Last updated on March 13, 2007. Information provided by Assistance Publique - Hôpitaux de Paris

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

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 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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

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

Intervention ^†

Drug: celiprolol

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

100

Start Date ^†

October 2003

Completion Date

October 2010

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 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 ^††

Location Countries ^†

France

Administrative Information Fields

NCT ID ^†

NCT00190411

Organization ID

AOM 01108

Secondary IDs ^††

P010309

Study Sponsor ^†

Assistance Publique - Hôpitaux de Paris

Collaborators ^††

Aventis Pharmaceuticals

Investigators ^†

Principal Investigator:

Pierre BOUTOUYRIE, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

March 2007

First Received Date ^†

September 13, 2005

Last Updated Date

March 13, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.