Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04405804
Status:
UNKNOWN
Last Update Posted:
2020-12-08
First Post:
2020-05-26
Brief Title:
Early Administration of Ivabradine in Children With Heart Failure
Sponsor:
Bambino Gesù Hospital and Research Institute
Organization:
Bambino Gesù Hospital and Research Institute
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASI-Child
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 andor symptoms related to bradycardia or for other safety reasons
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 andor symptoms related to bradycardia or for other safety reasons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-003902-29 | EUDRACT_NUMBER | None | None |