跳至主要内容
临床试验/NCT00585871
NCT00585871撤回不适用

Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

James Martins1 个研究点 分布在 1 个国家开始时间: 2006年5月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

clonidine 0.1 TID

干预措施: clonidine (Drug)

Metoprolol control group

Active Comparator

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

发起方
James Martins
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

James Martins

Professor

University of Iowa

研究点 (1)

Loading locations...

相似试验