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

Phase 4

Completed

• Conditions: frequent premature ventricular contractions; frequent ventricular ectopic beats; 10007521

• Registration Number: NL-OMON55422
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

- Age >= 1 year and < 18 years - Structurally normal heart confirmed by
echocardiography- PVCs > 15% on two different 24-hour Holter recording- With
or without asymptomatic VTniversitai

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 === -1 ? 0 : str.le

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The acute effect of flecainide and metoprolol on the reduction of PVCs as<br /><br>measured on Holter registration.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The function of the left and right ventricle as measured by echocardiography<br /><br>and cardiac resonance imaging, and NT-pro-BNP levels in the blood.</p><br>