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WithdrawnNCT03561935Updated Apr 23, 2024

Beta-blocker vs. Ic Antiarrhythmic Drug for PVC

An interventional study of Propafenone and Indenol in Premature Ventricular Complex, sponsored by Yong Seog Oh. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Yong Seog Oh · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Premature Ventricular Complex
03

In context

Ventricular Premature Complexes

102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.

Browse Ventricular Premature Complexes studies →

Lead sponsor

Yong Seog Oh is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • over 19 years old >6000 PVCs/24hrs

Exclusion criteria

Exclusion Criteria:

  • \<50% or Significant valvular disease (≥moderate) History of coronary artery disease Use of a concomitant antiarrhythmic agent Significant bradycardia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Propafenone group

    Prescribtion of propafenone for the management of premature ventricular complex

    Drug: Propafenone

  • Active comparator
    Indenol group

    Prescribtion of indenol for the management of premature ventricular complex

    Drug: Indenol

Interventions

  • DrugPropafenone

    prescribing propafenone for the management of premature ventricular complex

  • DrugIndenol

    prescribing indenol for the management of premature ventricular complex

06

What researchers measure

Primary outcomes

  1. Reduction in PVC frequency on 24hrs holter

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

    Time frame: two months after randomization

07

Study locations

1 site
  • Seoul St Mary's Hospital
    Seoul, Seo Ch-gu 137-701, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Jun 2019 and a completion of Nov 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 24, 2017
First posted
Jun 19, 2018
Start
Jun 2015
Primary completionEst.
Jun 1, 2019
CompletionEst.
Nov 1, 2019
Last update
Apr 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03561935
Lead sponsor
Yong Seog Oh
Responsible party
Yong Seog Oh (professor, Seoul St. Mary's Hospital) — Sponsor-investigator
First posted
Jun 19, 2018
Start date
Jun 2015
Primary completion
Jun 1, 2019 (estimated)
Completion
Nov 1, 2019 (estimated)
Last update
Apr 23, 2024

Study contacts

Yong-Seog Oh, MD,PhD
principal investigator · The Catholic University of Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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