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

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Pediatric Chronic Heart Failure

Countries: Japan

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.

Eligibility overview

Sex: ALL

Age: 1 Year to 17 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (28)

Ōbu, Aichi-ken, Japan
Toyoake, Aichi-ken, Japan
Kurume, Fukuoka, Japan
Kurume, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Tsukuba, Ibaraki, Japan
Kawasaki, Kanagawa, Japan
Yokohama, Kanagawa-ku, Japan
Tsu, Mie-ken, Japan
Nagasaki, Nagasaki, Japan
Ōmura, Nagasaki, Japan
Hidaka, Saitama, Japan
Saitama, Saitama, Japan
Hamamatsu, Shizuoka, Japan
Bunkyo Ku, Tokyo, Japan
Bunkyo Ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Fuchū, Tokyo, Japan
Fuchū, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shinagawa-ku, Tokyo, Japan
Shinjuku Ku, Tokyo, Japan
Toyama, Toyama, Japan
Akita, Japan
Fukuoka, Japan
Kumamoto, Japan
Okayama, Japan