Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- episodes of non-sustained ventricular tachycardia
研究概览
简要总结
Cardiac arrest or sustained VT (ventricular tachycardia) in patients with heart disease is best treated with an ICD (implantable cardioverter defibrillator). However, the ICD alone is not appropriate therapy for patients with frequent VT episodes. In fact frequent shocks for VT may predict a poorer prognosis. Anti-arrhythmic drugs are co-administered with ICDs in up to 50% of patients to prevent VT episodes, but antiarrhythmic drugs may have harmful effects. Thus improved drugs to prevent VT without interfering with ICD function are needed. Recent data including our own suggest that clonidine may be a new therapy to prevent ICD shocks. It may act centrally on sympathetic outflow and peripherally and selectively on cardiac Purkinje, to suppress and control VT occurring in patients. Our purpose is to test the hypothesis that clonidine reduces frequent VT better than beta blocker in patients with ICDs. After informed consent patients will be randomized in a single blind fashion to either clonidine or metoprolol given three times per day. Other prescribed drugs may be adjusted to promote toleration of the study drug. ICD interrogations of episodes of VT will be the primary endpoint. Device based NIPS (non-invasive programmed stimulation) testing in a subset of these patients will allow mechanistic understanding of the clonidine effect. All of the procedural techniques are in place as performed clinically; preliminary data are given showing feasibility of the project.
详细描述
we had wanted very commonly occurring VT episodes on ICD interrogation: 5 episodes/ 3 months. We could not enroll more than 2 patients most of which have interventions to prevent episodes. Thus we could not enroll patients and discontinued the study in the first year.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period
排除标准
- •No more than one shock/3 months
- •No contraindication to clonidine
- •Non-compliance
研究组 & 干预措施
Clonidine therapy group
clonidine 0.1 TID
干预措施: clonidine (Drug)
Metoprolol control group
metoprolol 25 TID
干预措施: metoprolol (Drug)
结局指标
主要结局
episodes of non-sustained ventricular tachycardia
时间窗: one year
次要结局
- defibrillator shocks(one year)
研究者
James Martins
Professor
University of Iowa
