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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26689
Enrollment
49
Registered
2017-02-06
Start date
2017-03-01
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

frequent premature ventricular contractions frequent ventricular ectopic beats left ventricular dysfunction anti-arrhythmic drugs children frequente premature ventriculaire contracties frequente overslagen van de hartkamers linker kamer dysfunctie anti-aritmica kinderen

Interventions

In a pediatric cohort of patients the acute effect of beta-blocker vs flecainide on the amount of PVCs will be tested in an open label cross-over design. After baseline function testing patients will

Sponsors

Leiden University Medical Center Leiden, the Netherlands
Lead Sponsor

Eligibility

Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: - Age ¡Ý 1 year and 15% on two different 24-hour Holter recording - With or without asymptomatic VT

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

MeasureTime frame
The acute effect of flecainide and metoprolol on the reduction of PVCs as measured on Holter registration.

Secondary

MeasureTime frame
The function of the left and right ventricle as measured by echocardiography and cardiac magneticresonance imaging, and NT-pro-BNP levels in the blood.

Contacts

Public ContactR.A. Bertels
r.a.bertels@lumc.nl+31715262835

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)