E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
frequent premature ventricular contractions |
frequente premature ventriculaire contracties |
|
E.1.1.1 | Medical condition in easily understood language |
frequent ventricular ectopic beats |
frequente overslagen van de hartkamers |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To test the acute effect of beta-blockers vs flecainide on the reduction of PVCs in a pediatric population. |
Het testen van het effect van flecainide op het aantal PVC's in vergelijking met metoprolol in groep pediatrische patienten. |
|
E.2.2 | Secondary objectives of the trial |
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. |
De secundaire doelstellingen zijn de prospective evaluatie van het effect van PVC's op de LV functie, van het effect van reductie van de PVC's door flecainide of metoprolol op de LV functie en het bepalen van additionele risico factoren voor het ontstaan van LV dysfunctie. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
- leeftijd ouder dan 1 jaar en jonger dan 18 jaar - structureel normaal hart bij echocardiografie - meer dan 15% PVCs bij twee verschillende 24-uurs Holter registraties - met of zonder asymptomatische VT |
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E.4 | Principal 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 |
- leeftijd jonger dan 1 jaar, gezien kans op spontaan verdwijnen van PVC's - structurele hartafwijkingen - status na cardiale chirurgie - myocarditis - cardiomyopathie - long QT syndroom - catecholaminerge polymorfe ventriculaire tachycardie (CPVT) - verapamil sensitive PVC / ventriculaire tachycardie (VT) - patienten met mentale retardatie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The acute effect of flecainide and metoprolol on the reduction of PVCs as measured on Holter registration. |
Het acute effect van flecanide en metoprolol op de vermindering van het aantal PVC's gemeten op Holter registratie. |
|
E.5.1.1 | 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. |
Het acute effect van flecainide en metoprolol wordt na 5-7 na de start van de medicatie bepaald, om eerst een steady state te bereiken. |
|
E.5.2 | 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. |
De functie van de linker en rechter kamer zoals gemeten op echocardiografie en cardiale MRI, en NT-pro-BNP waarden in het bloed. |
|
E.5.2.1 | 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. |
De secundaire eindpunten worden bepaald 5-7 na de start van de medicatie bepaald, om eerst een steady state te bereiken, en gedurende de follow-up elk half jaar, gedurende 4 jaar. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |