Back to resultsBeta-blocker vs. Ic Antiarrhythmic Drug for PVC
Primary Purpose
Premature Ventricular Complex
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propafenone
Indenol
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ventricular Complex
Eligibility Criteria
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
Sites / Locations
- Seoul St Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propafenone group
Indenol group
Arm Description
Prescribtion of propafenone for the management of premature ventricular complex
Prescribtion of indenol for the management of premature ventricular complex
Outcomes
Primary Outcome Measures
Reduction in PVC frequency on 24hrs holter
PVC reduction of >80% or <300 beats/day
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03561935
Brief Title
Beta-blocker vs. Ic Antiarrhythmic Drug for PVC
Official Title
Outcome of Medical Treatment for Idiopathic Premature Ventricular Complexes - Beta-blocker vs Ic Antiarrhythmic Agent; Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
November 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yong Seog Oh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ventricular Complex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propafenone group
Arm Type
Experimental
Arm Description
Prescribtion of propafenone for the management of premature ventricular complex
Arm Title
Indenol group
Arm Type
Active Comparator
Arm Description
Prescribtion of indenol for the management of premature ventricular complex
Intervention Type
Drug
Intervention Name(s)
Propafenone
Intervention Description
prescribing propafenone for the management of premature ventricular complex
Intervention Type
Drug
Intervention Name(s)
Indenol
Intervention Description
prescribing indenol for the management of premature ventricular complex
Primary Outcome Measure Information:
Title
Reduction in PVC frequency on 24hrs holter
Description
PVC reduction of >80% or <300 beats/day
Time Frame
two months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong-Seog Oh, MD,PhD
Phone
82-2-2258-6035
Email
oys@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ju Youn Kim, MD
Phone
82-10-5482-7307
Email
zzoo921@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Seog Oh, MD,PhD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St Mary's Hospital
City
Seoul
State/Province
Seo Ch-gu
ZIP/Postal Code
137-701
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ju Youn Kim, MD
Phone
82-10-5482-7307
Email
zzoo921@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong Seog Oh, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Beta-blocker vs. Ic Antiarrhythmic Drug for PVC
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