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Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

Primary Purpose

EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT, CHROMOSOME 2q31.2 DELETION SYNDROME

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
celiprolol
Control
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT focused on measuring Arteries, ultrasonography, Ehlers Danlos syndrome, Cardiovascular disease, beta adrenergic antagonists

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Celiprolol

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    January 15, 2013
    Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    Aventis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00190411
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2003 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris
    Collaborators
    Aventis Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT, CHROMOSOME 2q31.2 DELETION SYNDROME
    Keywords
    Arteries, ultrasonography, Ehlers Danlos syndrome, Cardiovascular disease, beta adrenergic antagonists

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Celiprolol
    Intervention Type
    Drug
    Intervention Name(s)
    celiprolol
    Other Intervention Name(s)
    celiprolol? Dose ranging 100 to 400 mg, dose adaptation, every 6 months by increment of 100 mg, based on tolerance
    Intervention Description
    celiprolol
    Intervention Type
    Drug
    Intervention Name(s)
    Control
    Intervention Description
    Untreated controls excluding betablockers
    Primary Outcome Measure Information:
    Title
    reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
    Description
    reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
    Time Frame
    during de study
    Secondary Outcome Measure Information:
    Title
    Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
    Description
    Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
    Time Frame
    during the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre BOUTOUYRIE, MD,PhD
    Organizational Affiliation
    Assistance Publique - Hôpitaux de Paris
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20825986
    Citation
    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. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7. Erratum In: Lancet. 2016 Aug 6;388(10044):564. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.
    Results Reference
    derived

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    Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

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