Status:
UNKNOWN
Early Administration of Ivabradine in Children With Heart Failure
Lead Sponsor:
Bambino Gesù Hospital and Research Institute
Collaborating Sponsors:
Ministero della Salute, Italy
Conditions:
Acute Heart Failure
Dilated Cardiomyopathy
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief 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%.
Detailed Description
The study is divided into a screening and enrollment visit (V1) where eligibility for treatment will be confirmed. Ivabradine will be administered to eligible patients with increasing dosage during th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04405804
Start Date
June 20 2020
End Date
May 1 2021
Last Update
December 8 2020
Active Locations (1)
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1
Bambino Gesù Hospital and Research Institute
Rome, Italy