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

Phase 1

Conditions: frequent premature ventricular contractions
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2017-001037-72-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

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 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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.