Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years.A randomised, double-blind, multicentre, placebo controlled, phase II/III dose-finding study with a PK/PD characterisation and a 1 year efficacy/safety evaluation.

Overview

No summary available.

Registry

who.int

Start Date

January 4, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\-Patients of both gender aged from 6 months to less than 18 years old
•\-Patients with dilated cardiomyopathy (DCM) receiving their usual treatment for chronic heart failure (CHF) at the optimal dose
•\-Patients in sinus rhythm
•Resting heart rate (HR) complying with the following criteria:
•.HR \>\= 105 bpm in the age\-subset \[6\-12\[ months
•.HR \>\= 95 bpm in the age\-subset \[1\-3\[ years
•.HR \>\= 75 bpm in the age\-subset \[3\-5\[ years
•.HR \>\= 70 bpm in the age\-subset \[5\-18\[ years.
•\-CHF class II to IV NYHA or Ross classification, stable for at leas 1 month prior to selection
•Left ventricular (LV) dysfunction with LVEF \<\= 45% documented by echocardiography

•Class I NYHA or Ross Classification (asymptomatic patients),
•Patients actively listed for transplantation at time of entry into the study or anticipated to undergo heart transplantation or corrective heart surgery during the 1 year following entry into the study,
•History of symptomatic or sustained (\= 30 sec) ventricular arrhythmia unless a cardioverter defibrillator was implanted,
•Patients with structural valvular disease or severe functional valvular disease requiring surgery,
•Significant systemic ventricular outflow obstruction,
•DCM secondary to muscular dystrophies, hemoglobinopathies, HIV, carnitine deficiency, anthracyclines,
•Patients requiring unauthorised concomitant treatment
•Serum creatinine \>2\.0 mg/dL or \>180 µmol/L (blood sample performed at ASSE visit),
•AST and/or ALT \> 3 upper normal limits (blood sample performed at ASSE visit),
•Unstable cardiovascular conditionat selection or inclusion.