A study which examines the results of medication on the amount of ectopic beats of the heart and the function of the heart.

The efficacy of flEcainide Compared To metOprolol in reducing Premature ventrIcular Complexes. An open label cross-over study in pediatric patients. - ECTOPIC trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001037-72-NL

Enrollment

Registered

2017-11-15

Start date

2017-12-01

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

frequent premature ventricular contractions

Interventions

Trade Name: metoprolol Pharmaceutical Form: Tablet Trade Name: flecainide Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 1 year and 15% on two different 24-hour Holter recording - With or without asymptomatic VT Are the trial subjects under 18? yes Number of subjects for this age range: 49 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Age < 1 year, because of the significant chance of spontaneous resolution of PVCs - Structural cardiac defects - History of cardiac surgery - Myocarditis - Cardiomyopathies - Long QT-syndrome - Catecholaminergic Polymorfic Ventricular Tachycardia (CPVT) - Verapamil sensitive PVC / Ventricular Tachycardia (VT) - Patients with mental retardation

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the acute effect of beta-blockers vs flecainide on the reduction of PVCs in a pediatric population. ;Secondary Objective: Secondary objectives are to perform a prospective evaluation of the effect of PVCs on LV function, to test the effect of reduction of PVCs by beta-blockers or flecainide on LV function and to determine additional risk factors for development of LV-dysfunction.;Primary end point(s): The acute effect of flecainide and metoprolol on the reduction of PVCs as measured on Holter registration.;Timepoint(s) of evaluation of this end point: The acute effect of flecainide and metoprolol will be determined 5-7 after the start of the medication to reach a steady state.	—

Measure

Time frame

Main Objective: To test the acute effect of beta-blockers vs flecainide on the reduction of PVCs in a pediatric population. ;Secondary Objective: Secondary objectives are to perform a prospective evaluation of the effect of PVCs on LV function, to test the effect of reduction of PVCs by beta-blockers or flecainide on LV function and to determine additional risk factors for development of LV-dysfunction.;Primary end point(s): The acute effect of flecainide and metoprolol on the reduction of PVCs as measured on Holter registration.;Timepoint(s) of evaluation of this end point: The acute effect of flecainide and metoprolol will be determined 5-7 after the start of the medication to reach a steady state.

—

Secondary

Measure	Time frame
Secondary end point(s): The function of the left and right ventricle as measured by echocardiography and cardiac resonance imaging, and NT-pro-BNP levels in the blood.;Timepoint(s) of evaluation of this end point: The secondary endpoints will be determined 5-7 after the start of the medication to reach a steady state and during follow-up every 6 months for four years.	—

Countries

Netherlands

Contacts

Public ContactMedical secretary

Leiden University Medical Center

+31715262835

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026