EUCTR2011-001292-39-HUActive, not recruitingNot Applicable
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 sites90 target enrollmentStarted: January 4, 2012Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-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
- •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
Exclusion Criteria
- •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.
Investigators
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