NCT00190411

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

January 16, 2013

Status Verified

March 1, 2007

Enrollment Period

7.5 years

First QC Date

September 13, 2005

Last Update Submit

January 15, 2013

Conditions

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

Keywords

ArteriesultrasonographyEhlers Danlos syndromeCardiovascular diseasebeta adrenergic antagonists

Outcome Measures

Primary Outcomes (1)

  • 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

    during de study

Secondary Outcomes (1)

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

    during the study

Study Arms (1)

Treatment

EXPERIMENTAL

Celiprolol

Drug: celiprololDrug: Control

Interventions

celiprololDRUG

celiprolol

Also known as: celiprolol? Dose ranging 100 to 400 mg, dose adaptation, every 6 months by increment of 100 mg, based on tolerance
Treatment
ControlDRUG

Untreated controls excluding betablockers

Treatment

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Proven disease,

You may not qualify if:

  • 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.
  • Refusal to participate in the study.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20825986DERIVED

MeSH Terms

Conditions

Ehlers-Danlos Syndrome, Type IVChromosome 2q31.2 Deletion SyndromeEhlers-Danlos SyndromeCardiovascular Diseases

Interventions

Celiprolol

Condition Hierarchy (Ancestors)

Aortic DissectionDissection, Blood VesselAneurysmVascular DiseasesHemostatic DisordersHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsPhenylurea CompoundsUreaAmidesAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Pierre BOUTOUYRIE, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

October 1, 2003

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

January 16, 2013

Record last verified: 2007-03