Early administration of ivabradine in hospitalized children for heart failure - Easi-child Pilot study

Conditions

Acute hearth failure in dilated cardiomyopathy

Brief summary

Number of patients, both in absolute numbers and as a percentage, showing a clinical response to treatment, defined as the difference (reduction) expressed as a percentage between 20% and 30%, calculated between the baseline (V1) heart rate in bpm and that recorded after 14 days (V3) of stable therapy with ivabradine.

Detailed description

Clinical response defined by the difference (reduction) expressed as a percentage, calculated between the heart rate value at baseline (V1) and at the end of the titration protocol (V2), and between the heart rate value recorded at the end of the stable therapy period with ivabradine after 4 months of follow-up (V4), Difference from baseline (V1) in heart rate in bpm at the end of the titration period (V2), after 14 days (V3) of stable therapy with ivabradine. After 4 months of follow-up (V4), Difference from baseline (V1) of serum NT-proBNP in pg/mL (mean (±SD)) at the end of the titration protocol (V2), after 14 days of stable therapy with ivabradine (V3), after 4 months of follow up (V4), Correlation between heart rate and NT-proBNP value (Pearson test), Difference from baseline (V1) in left ventricular function, calculated using 2D echocardiography (calculated left ventricular volumes and ejection fraction - mean (±SD), at the end of the titration protocol (V2), after 14 days of stable ivabradine therapy (V3), after 4 months of follow-up (V4)

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Interventions

DRUGIvabradine DOC Generici 5 mg

DRUGfilmomhulde tabletten

DRUGIvabradine DOC Generici 2

DRUG5 mg

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Number of patients, both in absolute numbers and as a percentage, showing a clinical response to treatment, defined as the difference (reduction) expressed as a percentage between 20% and 30%, calculated between the baseline (V1) heart rate in bpm and that recorded after 14 days (V3) of stable therapy with ivabradine.	—

Secondary

Measure	Time frame
Clinical response defined by the difference (reduction) expressed as a percentage, calculated between the heart rate value at baseline (V1) and at the end of the titration protocol (V2), and between the heart rate value recorded at the end of the stable therapy period with ivabradine after 4 months of follow-up (V4), Difference from baseline (V1) in heart rate in bpm at the end of the titration period (V2), after 14 days (V3) of stable therapy with ivabradine. After 4 months of follow-up (V4), Difference from baseline (V1) of serum NT-proBNP in pg/mL (mean (±SD)) at the end of the titration protocol (V2), after 14 days of stable therapy with ivabradine (V3), after 4 months of follow up (V4), Correlation between heart rate and NT-proBNP value (Pearson test), Difference from baseline (V1) in left ventricular function, calculated using 2D echocardiography (calculated left ventricular volumes and ejection fraction - mean (±SD), at the end of the titration protocol (V2), after 14 days of st	—

Measure

Time frame

Clinical response defined by the difference (reduction) expressed as a percentage, calculated between the heart rate value at baseline (V1) and at the end of the titration protocol (V2), and between the heart rate value recorded at the end of the stable therapy period with ivabradine after 4 months of follow-up (V4), Difference from baseline (V1) in heart rate in bpm at the end of the titration period (V2), after 14 days (V3) of stable therapy with ivabradine. After 4 months of follow-up (V4), Difference from baseline (V1) of serum NT-proBNP in pg/mL (mean (±SD)) at the end of the titration protocol (V2), after 14 days of stable therapy with ivabradine (V3), after 4 months of follow up (V4), Correlation between heart rate and NT-proBNP value (Pearson test), Difference from baseline (V1) in left ventricular function, calculated using 2D echocardiography (calculated left ventricular volumes and ejection fraction - mean (±SD), at the end of the titration protocol (V2), after 14 days of st

—

Countries

Italy

Outcome results

None listed