Beta-blocker vs. Ic Antiarrhythmic Drug for PVC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Premature Ventricular Complex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propafenone group

Prescribtion of propafenone for the management of premature ventricular complex

Group Type EXPERIMENTAL

Propafenone

Intervention Type DRUG

prescribing propafenone for the management of premature ventricular complex

Indenol group

Prescribtion of indenol for the management of premature ventricular complex

Group Type ACTIVE_COMPARATOR

Indenol

Intervention Type DRUG

prescribing indenol for the management of premature ventricular complex

Interventions

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Propafenone

prescribing propafenone for the management of premature ventricular complex

Intervention Type DRUG

Indenol

prescribing indenol for the management of premature ventricular complex

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* over 19 years old \>6000 PVCs/24hrs

Exclusion Criteria

* Left ventricular ejection fraction \<50% or Significant valvular disease (≥moderate) History of coronary artery disease Use of a concomitant antiarrhythmic agent Significant bradycardia

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No