MedTrace Logo

Early Administration of Ivabradine in Children With Heart Failure

NCT04405804 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-12-08

No results posted yet for this study

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%.

Conditions

  • Acute Heart Failure
  • Dilated Cardiomyopathy

Interventions

DRUG

Ivabradine 5Mg Tab

Initial dose of ivabradine will be: 0.02 mg/kg/dose twice daily in patients between 6-12 months 0.05 mg/kg/dose twice daily in patients between 1-3 years and 3-18 years with a weight \< 40 kg 2.5 mg/day in patients between 3-18 years with weight \> 40 kg During titration phase, the dose may be increased, maintained, reduced or discontinued in accordance with titration rules. The titration rules will be adjusted on the basis of age subset and of each patient's evaluation during the titration phase, whether or not the target heart rate is reached (HR ≥ 20% compared to baseline HR) and whether or not are present bradycardia (HR should be greater than predefined by a HR threshold per age subset) and/or bradycardia-related symptoms. Maximum dose to be reached will be: 0.2 mg/kg/dose twice daily in patients between 6-12 months 0.3 mg/kg/dose twice daily in patients between 1-3 years and 3-18 years with a weight \< 40 kg 15 mg/day in patients between 3-18 years, weight \> 40 kg

Sponsors & Collaborators

  • Ministero della Salute, Italy

    collaborator OTHER

  • Bambino Gesù Hospital and Research Institute

    lead OTHER

Principal Investigators

  • Rachele Adorisio, MD · Bambino Gesù Hospital and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-20
Primary Completion
2021-01-31
Completion
2021-05-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04405804 on ClinicalTrials.gov