Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure from ages 6 months to 18 years

Phase 2

Completed

• Conditions: Paediatric dilated cardiomyopathy and symptomatic chronic heart failure; Circulatory System; Cardiomyopathy

• Registration Number: ISRCTN60567801
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-10
• Study Completion: 2013-09-30
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Patients of both gender aged from 6 months to 18 years old
2. Patients with dilated cardiomyopathy (DCM) receiving their usual treatment for chronic heart failure (CHF) at the optimal dose
3. Patients in sinus rhythm
4. Resting heart rate (HR) complying with the following criteria:
4.1. HR >= 105 bpm in the age-subset [6-12] months
4.2. HR >= 95 bpm in the age-subset [1-3] years
4.3. HR >= 75 bpm in the age-subset [3-5] years
4.4. HR >= 70 bpm in the age-subset [5-18] years
5. CHF class II to IV NYHA or Ross classification, stable for at least 1 month prior to selection
6. Left ventricular (LV) dysfunction with left ventricular ejection fraction (LVEF) <= 45% documented by echocardiography LV dysfunction consecutive to idiopathic dilated cardiomyopathy (DCM), post-viral myocarditis DCM or ischaemic DCM

Exclusion Criteria

1. Class I NYHA or Ross Classification (asymptomatic patients)
2. Patients actively listed for transplantation at time of entry into the study or anticipated to undergo heart transplantation or corrective heartsurgery during the 1 year following entry into the study
3. History of symptomatic or sustained (= 30 sec) ventricular arrhythmiaunless a cardioverter defibrillator was implanted
4. Patients with structural valvular disease or severe functional valvulardisease requiring surgery
5. Significant systemic ventricular outflow obstruction
6. DCM secondary to muscular dystrophies, hemoglobinopathies, HIV,carnitine deficiency, anthracyclines
7. Patients requiring unauthorised concomitant treatment
8. Serum creatinine >2.0 mg/dL or >180 µmol/L (blood sampleperformed at ASSE visit)
9. AST and/or ALT > 3 upper normal limits (blood sample performed at ASSE visit)
10. Unstable cardiovascular condition at selection or inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified