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Beta-blocker vs. Ic Antiarrhythmic Drug for PVC

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ClinicalTrials.gov Identifier: NCT03561935
Recruitment Status : Recruiting
First Posted : June 19, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Yong Seog Oh, Seoul St. Mary's Hospital

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.

Condition or disease Intervention/treatment Phase
Premature Ventricular Complex Drug: Propafenone Drug: Indenol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome of Medical Treatment for Idiopathic Premature Ventricular Complexes - Beta-blocker vs Ic Antiarrhythmic Agent; Randomized Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propafenone group
Prescribtion of propafenone for the management of premature ventricular complex
Drug: Propafenone
prescribing propafenone for the management of premature ventricular complex

Active Comparator: Indenol group
Prescribtion of indenol for the management of premature ventricular complex
Drug: Indenol
prescribing indenol for the management of premature ventricular complex




Primary Outcome Measures :
  1. Reduction in PVC frequency on 24hrs holter [ Time Frame: two months after randomization ]
    PVC reduction of >80% or <300 beats/day



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561935


Contacts
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Contact: Yong-Seog Oh, MD,PhD 82-2-2258-6035 oys@catholic.ac.kr
Contact: Ju Youn Kim, MD 82-10-5482-7307 zzoo921@catholic.ac.kr

Locations
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Korea, Republic of
Seoul St Mary's Hospital Recruiting
Seoul, Seo Ch-gu, Korea, Republic of, 137-701
Contact: Ju Youn Kim, MD    82-10-5482-7307    zzoo921@catholic.ac.kr   
Principal Investigator: Yong Seog Oh, Ph.D         
Sponsors and Collaborators
Yong Seog Oh
Investigators
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Principal Investigator: Yong-Seog Oh, MD,PhD The Catholic University of Korea

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Responsible Party: Yong Seog Oh, professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT03561935     History of Changes
Other Study ID Numbers: PVC study
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Premature Birth
Ventricular Premature Complexes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Adrenergic beta-Antagonists
Propafenone
Anti-Arrhythmia Agents
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators