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

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 CHROMOSOME 2q31.2 DELETION SYNDROME	Drug: celiprolol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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 [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
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. [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.

Enrollment:	100
Study Start Date:	October 2003
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 celiprolol	Drug: celiprolol celiprolol Other Name: celiprolol

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 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.

Contacts and Locations

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

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 by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. Epub 2010 Sep 7.

Responsible Party:	Aurémie GUIMFACK, Department Clinical Research of developpement
ClinicalTrials.gov Identifier:	NCT00190411 History of Changes
Other Study ID Numbers:	P010309
Study First Received:	September 13, 2005
Last Updated:	May 3, 2011
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:

Ehlers-Danlos Syndrome
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Adrenergic beta-Antagonists
Celiprolol

Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on February 09, 2012