Early Administration of Ivabradine in Children With Heart Failure



Sponsor:   Bambino Gesù Hospital and Research Institute


Sommario: This is a monocentric, prospective, single arm, not for profit study. It is designed to
study the early use of ivabradine in patients with dilated cardiomyopathy and Ejection
Fraction (EF) < 45%.




TIPOLOGIA STUDIO

 
Interventistico



FASE

 
Fase 2




TRATTAMENTO

  
    
  






OBIETTIVO PRIMARIO


  
  • Misura: Heart rate in b.p.m. (mean (±SD) difference from baseline) at the end of maintenance
  • Tempo: At the end of the two weeks maintenance period (17-29 days from enrollment)
  • Descrizione: To assess the response to ivabradine on heart rate after 14 days of stable therapy




OBIETTIVO SECONDARIO


  
  • Misura: Heart rate in b.p.m. (mean (±SD) difference from baseline) at the end of follow-up
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess the response to ivabradine on heart rate after 16 weeks of follow-up
  • Misura: Serum NT-proBNP in pg/mL (mean (±SD) difference from baseline) at the end of maintenance
  • Tempo: At the end of the two weeks maintenance period (17-29 days from enrollment)
  • Descrizione: To assess the response to ivabradine on serum NT-proBNP levels after 14 days of stable
therapy
  • Misura: Serum NT-proBNP in pg/mL (mean (±SD) difference from baseline) at the end of follow-up
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess the response to ivabradine on serum NT-proBNP levels after 16 weeks of
follow-up
  • Misura: Correlation between heart rate and NT-proBNP value (Pearson correlation) at the end of maintenance
  • Tempo: At the end of the two weeks maintenance period (17-29 days from enrollment)
  • Descrizione: To assess the correlation between heart rate and serum NT-proBNP levels after 14 days of
stable therapy
  • Misura: Correlation between heart rate and NT-proBNP value (Pearson correlation) at the end of follow-up
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess the correlation between heart rate and serum NT-proBNP levels after 16 weeks of
follow-up
  • Misura: Left ventricular function, calculated by 2D echocardiographic technique (calculation of left ventricular volume and ejection fraction - mean (±SD) difference from baseline) at the end of maintenance
  • Tempo: At the end of the two weeks maintenance period (17-29 days from enrollment)
  • Descrizione: To assess EF, Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End
Systolic Volume (LVESV) after 14 days of stable therapy
  • Misura: Left ventricular function, calculated by 2D echocardiographic technique (calculation of left ventricular volume and ejection fraction - mean (±SD) difference from baseline) at the end of follow-up
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess EF, LVSV, LVDV after 16 weeks of follow-up
  • Misura: Systolic blood pressure in mmHg (mean (±SD) difference from baseline) at the end of maintenance
  • Tempo: At the end of the two weeks maintenance period (17-29 days from enrollment)
  • Descrizione: To assess the response to ivabradine on systolic blood pressure after 14 days of stable
therapy
  • Misura: Systolic blood pressure in mmHg (mean (±SD) difference from baseline) at the end of follow-up
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess the response to ivabradine on systolic blood pressure after 16 weeks of
follow-up
  • Misura: Use of inotropic drugs (number and % of patients who had to use inotropes at the end of maintenance)
  • Tempo: At the end of the two weeks maintenance period (17-29 days from enrollment)
  • Descrizione: To assess the need to resort to inotropic drugs within 14 days of stable ivabradine
therapy
  • Misura: Use of inotropic drugs (number and % of patients who had to use inotropes at the end of follow-up)
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess the need to resort to inotropic drugs within 16 weeks of follow-up
  • Misura: Number and % of dropouts at the end of maintenance
  • Tempo: At the end of the two weeks maintenance period (17-29 days from enrollment)
  • Descrizione: To assess the frequency of patients who exit from the study within 14 days of stable
ivabradine therapy
  • Misura: Number and % of dropouts at the end of follow-up
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess the frequency of patients who exit from the study within 16 weeks of follow-up
  • Misura: Time (days) from start of ivabradine therapy and new episode of acute heart failure, and/or implantation of mechanical assist device at the end of follow up
  • Tempo: At the end of the 16 weeks follow-up period (129-141 days from enrollment)
  • Descrizione: To assess the period within main cardiological events would occur after the start of
ivabradine therapy




CRITERI DI ELIGIBILITA'


    
             
  • 
        Criteri di inclusione e esclusione
        
    Inclusion Criteria:

  -  Dilated cardiomyopathy defined according to the indications of the Cardiomyopathy
     Task Force (dilation > 2 Standard Deviations (SD) and hypokinesia);

  -  Class NYHA/Ross ≥ II;

  -  Ejection fraction < 40%;

  -  Patients with acute heart failure episodes (both new episode and relapse) in the
     last three months;

  -  Systolic blood pressure > 50° age and height;

  -  Heart rate: 6-12 months: ≥105 bpm, >1 year <3 years: ≥95 bpm, 3-5 years: ≥75 bpm,
     5-18 years: >70 bpm.

Exclusion Criteria:

  -  Cardiogenic shock in the three months;

  -  Hypertrophic, restrictive or mixed cardiomyopathy;

  -  Acute lymphocytic myocarditis diagnosed with endomyocardial biopsy;

  -  Significant Valvular Pathology;

  -  Sinus block and congenital long QT syndrome;

  -  Atrial Fibrillation;

  -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 2.5
     times normal, bilirubin > 3 and creatinine > 2.5 mg/dL;

  -  Pregnancy and/or positive pregnancy test patients;

  -  Hypersensitivity to the active substance or any of the excipients;

  -  Participation in a clinical trial in which an experimental drug was administered
     within 30 days or 5 half-lives of the investigational drug;

  -  Chronic lung disease or other clinical condition that the investigating physician
     believes is incompatible with the study;

  -  eGFR <15 mL/min/1.73 m2.
    
        
    • 
    




SESSO

  
Tutti




  


ETA' MINIMA



Età Minima: 6 Months

Età Massima: 17 Years






LUOGO


  
Bambino Gesù Hospital and Research Institute
Rome	3169070,