Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Treatment
Celiprolol
干预措施: celiprolol (Drug)
Treatment
Celiprolol
干预措施: Control (Drug)
结局指标
主要结局
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
时间窗: during de study
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
次要结局
- Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.(during the study)