NCT03561935

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

4 years

First QC Date

April 24, 2017

Last Update Submit

April 20, 2024

Conditions

Premature Ventricular Complex

Outcome Measures

Primary Outcomes (1)

  • Reduction in PVC frequency on 24hrs holter

    PVC reduction of \>80% or \<300 beats/day

    two months after randomization

Study Arms (2)

Propafenone group

EXPERIMENTAL

Prescribtion of propafenone for the management of premature ventricular complex

Drug: Propafenone

Indenol group

ACTIVE COMPARATOR

Prescribtion of indenol for the management of premature ventricular complex

Drug: Indenol

Interventions

PropafenoneDRUG

prescribing propafenone for the management of premature ventricular complex

Propafenone group
IndenolDRUG

prescribing indenol for the management of premature ventricular complex

Indenol group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St Mary's Hospital

Seoul, Seo Ch-gu, 137-701, South Korea

Location

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Propafenone1-indenol

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Yong-Seog Oh, MD,PhD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 24, 2017

First Posted

June 19, 2018

Study Start

June 1, 2015

Primary Completion

June 1, 2019

Study Completion

November 1, 2019

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

KR(1)