DAPERB 3,4-DiAminoPyridine and Electrophysiological Response in Brugada Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Electrophysiological study result (re-inducibility or not) 45 minutes after drug intake
研究概览
简要总结
The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD) is implanted to prevent sudden cardiac death. ICD are however associated with potential complications and are not available in all countries.Pharmacological blockade of specific ion channels (Ito) represents a promising therapeutic approach in this syndrome.The 3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that can be used in humans.The aim of the study is to evaluate the effect of 3,4-DAP on ventricular arrhythmia inducibility in Brugada patients requiring an electrophysiological study for arrhythmic risk stratification.
详细描述
Background:
The Brugada syndrome is a rare disease potentially leading to severe arrhythmic events in otherwise healthy subjects.In many patients an Implantable cardiovertor defibrillator (ICD) is implanted to prevent sudden cardiac death. ICD are however associated with potential complications and are not available in all countries.Pharmacological blockade of specific ion channels (Ito) represents a promising therapeutic approach in this syndrome. Experimental data show that increased Ito current may be associated with both the ECG feature and arrhythmogenic substrate observed in the syndrome. Moreover, Ito blockade reverse the ECG abnormalities and suppress arrhythmogenicity.The 3,4-diaminopyridine (3,4-DAP) is a pharmacological Ito blocker that is already used in humans for another indication.
Main objective:
The aim of the study is to evaluate the effect of 3,4-DAP on ventricular arrhythmia inducibility in Brugada patients requiring an electrophysiological study for arrhythmic risk stratification.
First end point:
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
- Double (Participant, Investigator)
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
- •Man or woman ≥ 18 years old
- •Brugada syndrome diagnosed with a type 1 ECG either spontaneous or drug-induced
- •Electrophysiological study indicated for arrhythmic risk stratification purpose
- •Inducibility of a sustained ventricular tachycardia (> 30 seconds) or ventricular fibrillation requiring defibrillation
- •Physical medical examination
- •Signed written informed consent
排除标准
- •Personal or familial history of epilepsy
- •Pregnancy
- •Body weight > 100 kg
- •the need of >1 counter shock for defibrillation
- •Alcohol or cocaine consumption during the protocol
- •Class I (with the exception of local anaesthesia by lidocaine), II, III and IV antiarrhythmic drugs, antidepressant drugs, ATP dependent potassium channel activators, sultopride not stopped for > 7 halve-lives
- •No medical insurance
研究组 & 干预措施
1
3,4-Di-amino-Pyridine : a single 20 mg dosing
干预措施: 3,4-Di-amino-Pyridine (Drug)
2
干预措施: placebo (Drug)
结局指标
主要结局
Electrophysiological study result (re-inducibility or not) 45 minutes after drug intake
时间窗: 45 minutes after drug intake
次要结局
- the effect of 3,4-DAP on ST segment elevation in Brugada patients (45 minutes)(at 45 minutes)
- the relationship between 3,4-DAP plasma concentration measured at 45 minutes and electrophysiological study result and ST segment elevation(at 45 minutes)