跳至主要内容
临床试验/NCT03561935
NCT03561935撤回不适用

Outcome of Medical Treatment for Idiopathic Premature Ventricular Complexes - Beta-blocker vs Ic Antiarrhythmic Agent; Randomized Controlled Trial

Yong Seog Oh1 个研究点 分布在 1 个国家开始时间: 2015年6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
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

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

Experimental

Prescribtion of propafenone for the management of premature ventricular complex

干预措施: Propafenone (Drug)

Indenol group

Active Comparator

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

发起方
Yong Seog Oh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yong Seog Oh

professor

Seoul St. Mary's Hospital

研究点 (1)

Loading locations...

相似试验

Beta-blocker vs. Ic Antiarrhythmic Drug for PVC | 临床试验