Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

This study is ongoing, but not recruiting participants.

First Received: September 13, 2005 Last Updated: March 13, 2007 History of Changes

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	Aventis Pharmaceuticals
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00190411

Purpose

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

Condition	Intervention	Phase
Ehlers-Danlos Syndrome, Type Iv, Autosomal Dominant Gene Map Locus 2q31	Drug: celiprolol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: Ehlers-Danlos syndrome hemophilia

MedlinePlus related topics: Ehlers-Danlos Syndrome

Drug Information available for: Celiprolol Celiprolol hydrochloride

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	100
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2010

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.

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190411

Locations

France
Clinical Pharmacology Unit, HEGP, AP-HP
Paris, France, 75015

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Aventis Pharmaceuticals

Investigators

Principal Investigator:

Pierre BOUTOUYRIE, MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Study ID Numbers:	AOM 01108, P010309
Study First Received:	September 13, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00190411 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Arteries
ultrasonography
Ehlers Danlos syndrome
Cardiovascular disease
beta adrenergic antagonists

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Ehlers-Danlos Syndrome
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hemostatic Disorders
Hemorrhagic Disorders
Pathologic Processes
Therapeutic Uses
Syndrome
Connective Tissue Diseases
Adrenergic beta-Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents

Congenital Abnormalities
Skin Diseases, Genetic
Sympatholytics
Disease
Collagen Diseases
Skin Diseases
Celiprolol
Hematologic Diseases
Skin Abnormalities
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Genetic Diseases, Inborn
Autonomic Agents

ClinicalTrials.gov processed this record on November 30, 2009