IVABRADINE HYDROCHLORIDE for Acute heart failure | Dilated cardiomyopathy

Inclusion criteria

• {"criterion_text":"- Patients ≥ 3 years of age and under 18 years of age and weight ≥ 25 kg;\n- Dilated cardiomyopathy defined according to the indications of the Cardiomyopathy Task Force (dilation > 2 SD and hypokinesia);\n- NYHA/Ross Classification ≥ II;\n- Ejection fraction < 40%;\n- Patients with episode of acute heart failure (both de novo and relapse) in the last three months;\n- Systolic blood pressure > 50th percentile per age and height;\n- Heart rate: 3-5 years ≥75 bpm;\n- 5-18 years >70 bpm;\n- Signed Informed Consent Form (ICF)/Assent by the subject"}

Exclusion criteria

• {"criterion_text":"- Hypertrophic, restrictive or mixed cardiomyopathy;\n- Acute lymphocytic myocarditis diagnosed by endomyocardial biopsy;\n- Significant Valvular Pathology;\n- Sinoatrial block and congenital long QT-syndrome;\n- Atrial fibrillation;\n- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels > 2.5 times above the normal values, bilirubin > 3mg/dL and creatinine > 2.5 mg/dL.\n- Patients who are pregnant and/or have a positive pregnancy test\n- Hypersensitivity to the active substance or to any of the excipients.\n- Participation in a clinical study in which an experimental drug was administered within 30 days or 5 half-lives of the study drug.\n- Chronic lung disease or other clinical condition that, in the opinion of the investigator, is incompatible with the study.\n- eGFR <15 mL/min/1.73 m2\n- Inability to swallow tablets."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Clinical response defined as a reduction of heart rate between 20% and 30% from baseline (V1) to day 14 (V3) of stable therapy; reported as number and percentage of patients meeting this criterion (heart rate measured in bpm at specified visits V1 and V3)."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Percentage reduction in heart rate between V1 and V2, and between V1 and V4; heart rate measured in bpm at visits V1, V2, and V4."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Absolute difference in bpm from baseline (V1) measured at V2, V3 (14 days), and V4 (4 months)."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change in serum NT-proBNP concentration (pg/mL), reported as mean ± SD, measured at V1, V2, V3, and V4."}
• {"endpoint_text":"- Correlation between heart rate and NT-proBNP value (Pearson test)","definition_or_measurement_approach":"Statistical correlation (Pearson) between heart rate values and NT-proBNP measurements across visits."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Change in left ventricular volumes and ejection fraction measured by 2D echocardiography, reported as mean ± SD at V2, V3, and V4 compared to baseline V1."}

Italy

Earliest CTIS Part Ii Submission Date

28-01-2025

Latest Decision Or Authorization Date

22-01-2026

Processing Time Days

359

Number Of Sites

1

Number Of Participants

9

Primary sponsor

Full Name

Ospedale Pediatrico Bambino Gesu

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"","full_name":"Ministero della Salute, Ricerca Corrente","duties_or_roles":"Monetary support / funding","organisation_type":""}