BRD 06/2-D (Quidam) "Evaluation of the Interest of Oral Hydroquinidine Administration to Treat Patients With Brugada Syndrome, High Cardiac Arrhythmic Risk and Implanted With an Implantable Cardioverter Defibrillator"
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 17
- 主要终点
- To determine whether hydroquinidine enhances time length before arisen of an appropriate shock registered on the automatic implantable defibrillator (meaning due to ventricular arrhythmia)
研究概览
简要总结
The specific aim of this study is to determine whether hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia detected by the automatic implantable defibrillator (ICD).
详细描述
During this double-blind randomized cross-over study, patient will receive during 18 months treatment 1 (hydroquinidine or placebo) and, after 7 days of wash-out, patient will receive treatment 2 (meaning for example hydroquinidine if treatment 1 was placebo). Time length before arisen of an appropriate shock registered on the defibrillator (meaning due to ventricular arrhythmia) will be assessed during treatment 1 period and treatment 2 period.We hypothesized that hydroquinidine administration will enhance time length before arisen of an appropriate shock and thus mean that hydroquinidine administration can prevent heart from appearance of ventricular arrhythmia. Patient's defibrillator recordings will be analysed every 6 months plus when patient experiences an ICD shock. If the shock delivered by the ICD is appropriate and happens during treatment 1 period, patient will switch to treatment 2 period after 7 days of wash-out. If the shock delivered by the ICD is appropriate and happens during treatment 2 period, study will be finished for this patient.Before starting the study, each patient will test which dose of hydroquinidine she/he requires to have an hydroquinidine concentration in her/his blood included between 3 and 6 µmol/L.
Planned enrollment: 200 subjects (60 being symptomatic with histories of aborted sudden cardiac death or of ventricular fibrillation, 70 being symptomatic with histories of syncope considered as of arrhythmic origin, 70 being asymptomatic with a spontaneous type 1 ECG and a positive electrophysiological exploration)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult (at least 18 years of age)
- •Informed consent form signed
- •Subject affiliated to French health insurance (Sécurité Sociale)
- •Type 1 Brugada syndrome either symptomatic or asymptomatic
- •Not pregnant, taking oral contraceptive measure if able to procreate
- •If patient with asymptomatic type 1 Brugada, electrophysiological exploration must be positive at study inclusion
- •No current intake of "betablocking" medicine used in cardiac insufficiency (bisoprolol, carvedilol, metoprolol)
- •No current myasthenia
- •No current treatment with halofantrine, pentamidine, moxifloxacin
- •No current treatment with some neuroleptics
- •Known hypersensitivity to hydroquinidine
- •Intolerance to fructose, syndrome of glucose or galactose malabsorption, deficit in sucrase isomaltase- Cardiac insufficiency
- •Histories of "torsades de pointe"
- •Intake of medicine giving "torsades de pointe"
排除标准
- •Subject not fulfilling inclusion criteria
- •Subject being before study entry under hydroquinidine treatment but either at a dose > 3 capsules per day or at a dose of 1, 2 or 3 capsules per day but with a plasmatic hydroquinidine concentration >6µmol/L or <3 µmol/L
研究组 & 干预措施
hydroquinidine
As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 months.
干预措施: hydroquinidine (Drug)
capsules of sugar
As it is a cross-over study, patient will taken treatment 1 for 18 months (ex: hydroquinidine) and then treatment 2 (placebo in this case) for 18 months.
干预措施: placebo (sugar) (Drug)
结局指标
主要结局
To determine whether hydroquinidine enhances time length before arisen of an appropriate shock registered on the automatic implantable defibrillator (meaning due to ventricular arrhythmia)
时间窗: 3 years after patient randomization
次要结局
- To evaluate interest of the electrophysiological exploration for determining chances of success of an hydroquinidine(3 years after patient randomization)
- To evaluate number of syncope reported by the patient but for which no ventricular arrhythmias has been detected by the defibrillator(3 years after patient randomization)
- To evaluate the number and frequency of adverse events appeared under hydroquinidine treatment(3 years after patient randomization)
- To evaluate number and frequency of inappropriate shock with and without hydroquinidine(3 years after patient randomization)
- To evaluate the number of tachycardia or of ventricular fibrillations detected by the defibrillator but not having required any treatment(3 years after patient randomization)