Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)

Launched by NOVARTIS PHARMACEUTICALS · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a medication called Entresto, which comes in tablet and granule forms, for children with chronic heart failure. The trial aims to see how well Entresto works and how safe it is when used in real-life situations over a period of up to 52 weeks. It is open to pediatric patients aged 1 to 17 years who are starting Entresto for the first time due to their heart condition.

To participate, families must provide written consent, and there are certain criteria that need to be met. For example, children who have never used medications containing the same ingredient as Entresto or those who have specific medical conditions that could make Entresto unsafe for them are not eligible. Participants will receive Entresto as part of their usual care, and doctors will monitor their health throughout the trial to ensure safety and effectiveness. It’s important for families to discuss this opportunity with their healthcare team to see if it’s a good fit for their child's needs.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
• • 2. Patients who received Entresto for the first time under the indication of chronic heart failure
• • 3. Pediatric patients aged 1 to \< 18 years old at the start of treatment with Entresto
• • Exclusion criteria
• • 1. Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
• • 2. Patients for whom Entresto is contraindicated according to the package insert
• • Patients with a history of hypersensitivity to any ingredients of Entresto
• • Patients currently under treatment with angiotensin-converting enzyme inhibitors or within 36 hours of discontinuation of treatment with angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, lisinopril hydrate).
• • Patients with a history of angioedema (including angioedema due to angiotensin II receptor blockers or angiotensin-converting enzyme inhibitors, hereditary angioedema, acquired angioedema, and idiopathic angioedema etc.)
• • Patients with diabetes mellitus under treatment with aliskiren fumarate (excluding patients with markedly poorly controlled blood pressure despite other antihypertensive therapies)
• • Patients with severe hepatic impairment (Child-Pugh class C)
• • Pregnant women or women who may be pregnant