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

Recruiting now

Conditions studied: Pediatric Chronic Heart Failure

In brief

This is multicenter, single-arm, non-interventional, centrally enrolled specified drug-use survey to investigate the safety of Entresto Tablets or Entresto Granules for Pediatric in pediatric patients with chronic heart failure in actual clinical settings for up to 52 weeks after administration.

Key facts

Study ID

NCT06659393

Run by

Novartis Pharmaceuticals

People needed

30

Starts

2024-12-19

Expected to finish

2027-11-30

Last updated by the study team

2026-04-13

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
• Patients who received Entresto for the first time under the indication of chronic heart failure
• Pediatric patients aged 1 to < 18 years old at the start of treatment with Entresto

You may not qualify if…

• Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
• 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

Where it is running

• Novartis Investigative Site — Okayama, Japan (enrolling)
• Novartis Investigative Site — Toyoake, Aichi-ken, Japan (enrolling)
• Novartis Investigative Site — Kurume, Fukuoka, Japan (enrolling)
• Novartis Investigative Site — Kurume, Fukuoka, Japan (enrolling)
• Novartis Investigative Site — Sapporo, Hokkaido, Japan (enrolling)
• Novartis Investigative Site — Tsukuba, Ibaraki, Japan (enrolling)
• Novartis Investigative Site — Kawasaki, Kanagawa, Japan (enrolling)
• Novartis Investigative Site — Yokohama, Kanagawa-ku, Japan (enrolling)
• Novartis Investigative Site — Tsu, Mie-ken, Japan (enrolling)
• Novartis Investigative Site — Nagasaki, Nagasaki, Japan (enrolling)
• Novartis Investigative Site — Ōmura, Nagasaki, Japan (enrolling)
• Novartis Investigative Site — Hidaka, Saitama, Japan (enrolling)
• Novartis Investigative Site — Saitama, Saitama, Japan (enrolling)
• Novartis Investigative Site — Hamamatsu, Shizuoka, Japan (enrolling)
• Novartis Investigative Site — Bunkyo Ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Bunkyo Ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Bunkyo-ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Fuchū, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Fuchū, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Ōta-ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Setagaya-ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Shinagawa-ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Shinjuku Ku, Tokyo, Japan (enrolling)
• Novartis Investigative Site — Toyama, Toyama, Japan (enrolling)
• Novartis Investigative Site — Akita, Japan (enrolling)

Full record on ClinicalTrials.gov

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