Text Size

Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190411
First received: September 13, 2005
Last updated: January 15, 2013
Last verified: March 2007
History of Changes
  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
Drug: Control
 Phase 4

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:

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: 54
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: Treatment
Celiprolol
 Drug: celiprolol
celiprolol
Other Names:
  • celiprolol
  • 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

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):

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00190411     History of Changes
Other Study ID Numbers: P010309
Study First Received: September 13, 2005
Last Updated: January 15, 2013
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 May 16, 2013