Post-marketing Surveillance Protocol Number; CLCZ696F1401

JRCT ID: jRCT2031240443

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pediatric chronic heart failure
• Date of first enrollment: 30/11/2024
• Target sample size: 33
• Study type: Observational

Outcome(s)

• Primary Outcome: Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 18age old
• Gender: Both

Include 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

Exclude criteria

1.Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for postmarketing 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

Related Information

• Primary Sponsor: Sugimoto Toshiya