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.

Institut de Recherches Internationales Servier0 sites116 target enrollmentStarted: August 24, 2011Last updated: June 30, 2019

Conditions

Drugs

Trial Snapshot

No summary available.

•-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
•LV dysfunction consecutive to idiopathic DCM, post-viral myocarditis DCM or ischaemic DCM, left ventricular non compaction with DCM as primary condition or post-anthracyclines DCM (provided the treatment by anthracyclines was stopped at least two years prior to the selection into the study)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 90
•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

•Class I NYHA or Ross Classification (asymptomatic patients),
•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,
•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 condition at selection or inclusion.
•A girl having childbearing potential and sexually active not having contraception,

Sponsor