Beta-blocker vs. Ic Antiarrhythmic Drug for PVC

Premature Ventricular Complex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03561935
• Other study ID #: PVC study
• Status: Withdrawn
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 1, 2019

Study information

• Verified date: April 2024
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Ventricular Complex
• Ventricular Premature Complexes

Intervention

Drug:
• Propafenone
prescribing propafenone for the management of premature ventricular complex
• Indenol
prescribing indenol for the management of premature ventricular complex

Locations

Country	Name	City	State
Korea, Republic of	Seoul St Mary's Hospital	Seoul	Seo Ch-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yong Seog Oh

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in PVC frequency on 24hrs holter	PVC reduction of >80% or <300 beats/day	two months after randomization