Early Administration of Ivabradine in Children With Heart Failure

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Brief Title

Early Administration of Ivabradine in Children With Heart Failure

Official Title

A Monocentric, Open Label, Single Arm, Pilot Study on the Early Administration of Ivabradine in Children Aged >6 Months and <18 Years With Dilated Cardiomyopathy and Acute Heart Failure

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 the titration period (TP) which will last from a minimum of 3 days
      to a maximum of 15 days. This will be followed by a maintenance period (MP) of the drug for a
      further 14 days. The follow-up period (FU) will last 4 months.

      The dose of ACE inhibitors will be introduced after 72 hours of clinical stability after the
      introduction of titrated ivabradine at maximum dose according to protocol. The
      anti-aldosterone will be introduced 24 hours after the introduction of ivabradine. The
      diuretic will not be modified during the titration phase of the drug, unless there is
      clinical necessity.

      During the FU ivabradine will be continued at stable dosage, in order to maintain the target
      heart rate (HR) reached during the maintenance phase (HR > 80 bpm, in the group of patients
      older than 6-12 months, or HR > 70 bpm in patients aged 1-3 years or HR > 50 bpm between 3-18
      years). In all patients, the drug dose will be decreased or discontinued in case of
      bradycardia (HR< 80 bpm in patients 6-12 months, HR< 70 bpm in patients 1-3 years of age or
      HR< 60 bpm in patients 3-18 years of age) and/or symptoms related to bradycardia or for other
      safety reasons.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Heart rate in b.p.m. (mean (±SD) difference from baseline) at the end of maintenance

Secondary Outcome

 Heart rate in b.p.m. (mean (±SD) difference from baseline) at the end of follow-up

Condition

Acute Heart Failure

Intervention

Ivabradine 5Mg Tab

Study Arms / Comparison Groups

 Ivabradine
Description:  Eligible patients will be given treatment with ivabradine during a titration period which will last from a minimum of 3 days to a maximum of 15 days. This will be followed by a maintenance period of another 14 days. At the end of maintenance period, primary endpoint will be assessed. After maintenance period, the patient will continue ivabradine at the same dosage during a follow-up period that will last 4 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

9

Start Date

May 2020

Completion Date

April 2021

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria:

        Written informed consent of the person(s) legally entitled to give consent or the parent(s)
        / legal representative(s) of the child(ren) according to national law;

        Assent in prepubescents and adolescents

        Patients > 6 months of age and under 18 years of age

        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
      

Gender

All

Ages

6 Months - 17 Years

Accepts Healthy Volunteers

No

Contacts

Rachele Adorisio, MD, +393402776171, [email protected]



Administrative Informations


NCT ID

NCT04405804

Organization ID

1986 / 2019

Secondary IDs

2019-003902-29

Responsible Party

Principal Investigator

Study Sponsor

Bambino Gesù Hospital and Research Institute

Collaborators

 Ministero della Salute, Italy

Study Sponsor

Rachele Adorisio, MD, Principal Investigator, Bambino Gesù Hospital and Research Institute


Verification Date

May 2020