EUCTR2008-000994-39-FR进行中（未招募）不适用
Evaluation de l'intérêt d'un traitement par hydroquinidine pour la prise en charge des patients atteints d'un syndrome de Brugada à risque rythmique élevé et implantés d'un défibrillateur - QUIDAM
Centre Hospitalier Universitaire de Nantes0 个研究点开始时间: 2008年4月7日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Criteria for inclusion: Patients aged 18 or > 18, presenting a type I Brugada syndrome, having an Implantable Automatic Defibrillator (IAD) and being either symptomatic [ previous occurrence of cardiac arrest or ventricular fibrillation reduced by the IAD, OR previous occurrence of syncope suggesting cardiac rhythm trouble] or either asymptomatic, all patients being affiliated to social security, having given their written informed consent, having no known allergy to hydroquinidine.
- •Criteria for randomization :
- •- Those above listed
- •- For patients with asymptomatic Brugada syndrome: positive electrophysiological exploration at the visit of inclusion
- •- Absence of hypersensitivity reaction after intake of one capsule of hydroquinidine
- •- No relevant abnormality in the electrocardiogram after 3 to 5 days of hydroquinidine treatment
- •- No relevant abnormality in blood formula
- •The study will allow the randomization of:
- •- 60 patients with symptomatic type I Brugada syndrome having presented a cardiac arrest or a ventricular fibrillation reduced by the IAD
- •- 70 patients symptomatic type I Brugada syndrome who have presented a syncope suggesting cardiac rhythm trouble
- •- 70 patients asymptomatic but with spontaneous type I electrocardiogram and for which the electrophysiological exploration induced a severe rhythm trouble
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Criteria of non inclusion :
- •- Patients not presenting the inclusion criteria
- •- Pregnancy or lactation
- •- Female of procreating age without contraceptive methods
- •- contra-indications to the use of hydroquinidine (ex: intolerance to fructose, myasthenia,…)
- •Criteria for non randomization :
- •- Those above listed
- •- Patient with asymptomatic Brugada syndrome presenting a negative electrophysiological exploration at the visit of inclusion
- •- Hypersensitivity reaction after intake of one capsule of hydroquinidine
- •- Relevant abnormality in the electrocardiogram after 3 to 5 days of hydroquinidine treatment
- •- Relevant abnormality in blood formula
研究者
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