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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propafenone group | Experimental | Prescribtion of propafenone for the management of premature ventricular complex |
|
| Indenol group | Active Comparator | Prescribtion of indenol for the management of premature ventricular complex |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propafenone | Drug | prescribing propafenone for the management of premature ventricular complex |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in PVC frequency on 24hrs holter | PVC reduction of >80% or <300 beats/day | two months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Seog Oh, MD,PhD | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St Mary's Hospital | Seoul | Seo Ch-gu | 137-701 | South Korea |
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D011405 | Propafenone |
| C093580 | 1-indenol |
| ID | Term |
|---|---|
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Indenol | Drug | prescribing indenol for the management of premature ventricular complex |
|
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |