Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190411

Enrollment

Registered

2005-09-19

Start date

2003-10-31

Completion date

2011-04-30

Last updated

2013-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Arteries, ultrasonography, Ehlers Danlos syndrome, Cardiovascular disease, beta adrenergic antagonists

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.

Interventions

DRUGceliprolol

celiprolol

DRUGControl

Untreated controls excluding betablockers

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026