Early Administration of Ivabradine in Children With Heart Failure

• Status: Enrolling by invitation
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bambino Gesù Hospital and Research Institute
• Collaborator: Ministero della Salute, Italy

Criteria

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.