Outcome of Medical Treatment for Idiopathic Premature Ventricular Complexes - Beta-blocker vs Ic Antiarrhythmic Agent; Randomized Controlled Trial
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
- Reduction in PVC frequency on 24hrs holter
研究概览
简要总结
The standard medical therapy of idiopathic premature ventricular complex consists of beta blocker and Ic antiarrhythmic agent. However, the difference in the efficacy of two drugs has not been well investigated. This prospective randomized study aimed to compare the efficacy of beta-blocker and Ic antiarrhythmic agent in the treatment of symptomatic patients with idiopathic premature ventricular complex.
详细描述
A premature ventricular complex is frequently observed in routine clinical practice and patients without structural heart disease occasionally have benign outcomes. The initial therapy of symptomatic premature ventricular complex is medical treatment with beta-blocker, calcium channel blocker or antiarrhythmic agents. However, no large prospective study has been performed to identify the difference in the efficacy between drugs. The current study was designed to compare the efficacy between beta-blocker and class Ic antiarrhythmic agent. Patient with symptomatic PVC more than 6000 episode per 24 hours is included. Exclusion criteria are evidence of structural heart disease, coronary heart disease, significant bradycardia or use of a concomitant antiarrhythmic agent. Patients are randomized into beta-blocker group (propranolol) and Ic antiarrhythmic agent group (propafenone). Response to the drug is evaluated after 2 months from randomization by 24 hours Holter and questionnaire. The primary endpoint is more than 80% PVC reduction or PVC burden less than 300 beats per 24 hours. The secondary endpoint is patient's symptom evaluated by questionnaire and the number of PVCs measured in 24 hours Holter.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 19 years old >6000 PVCs/24hrs
排除标准
- •Left ventricular ejection fraction <50% or Significant valvular disease (≥moderate) History of coronary artery disease Use of a concomitant antiarrhythmic agent Significant bradycardia
研究组 & 干预措施
Propafenone group
Prescribtion of propafenone for the management of premature ventricular complex
干预措施: Propafenone (Drug)
Indenol group
Prescribtion of indenol for the management of premature ventricular complex
干预措施: Indenol (Drug)
结局指标
主要结局
Reduction in PVC frequency on 24hrs holter
时间窗: two months after randomization
PVC reduction of \>80% or \<300 beats/day
次要结局
未报告次要终点
研究者
Yong Seog Oh
professor
Seoul St. Mary's Hospital
