Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

January 15, 2013 updated by: Assistance Publique - Hôpitaux de Paris

Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Celiprolol
Drug: celiprolol
celiprolol
Other Names:
  • celiprolol? Dose ranging 100 to 400 mg, dose adaptation
  • every 6 months by increment of 100 mg, based on tolerance
Drug: Control
Untreated controls excluding betablockers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
Time Frame: during de study
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
during de study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
Time Frame: during the study
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
during the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Pierre BOUTOUYRIE, MD,PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2013

Last Update Submitted That Met QC Criteria

January 15, 2013

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P010309

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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