Last Update: Apr 13, 2026 Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401) ClinicalTrials.gov Identifier: [NCT06659393](https://clinicaltrials.gov/ct2/show/NCT06659393) Novartis Reference Number:CLCZ696F1401 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description 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. This specified drug-use survey is conducted to collect information on the safety specifications of Entresto in pediatric patients with chronic heart failure in Japan in actual clinical settings, and to investigate the occurrence of events related to the safety specifications, the risk factors associated with these events, and the status of Entresto administration including the accidental administration of capsule-shaped container (Granules for Pediatric). The subjects of this study are pediatric patients and a long-term observation of 1 year (52 weeks) has been set. Condition Pediatric Chronic Heart Failure Overall Status Recruiting Number of Participants30 Start Date Dec 19, 2024 Completion Date Nov 30, 2027 Gender All Age(s) 1 Year - 17 Years (Child) ## 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 Japan #### Novartis Investigative Site Recruiting Sapporo,Hokkaido,060-8648,Japan #### Novartis Investigative Site Recruiting Okayama,7008558,Japan #### Novartis Investigative Site Recruiting Toyama,Toyama,9300194,Japan #### Novartis Investigative Site Recruiting Shinjuku Ku,Tokyo,1628666,Japan #### Novartis Investigative Site Recruiting Shinagawa-ku,Tokyo,1428666,Japan #### Novartis Investigative Site Recruiting Setagaya-ku,Tokyo,1578535,Japan #### Novartis Investigative Site Recruiting Fuchū,Tokyo,1838561,Japan #### Novartis Investigative Site Recruiting Bunkyo Ku,Tokyo,1138431,Japan #### Novartis Investigative Site Recruiting Bunkyo Ku,Tokyo,113-8655,Japan #### Novartis Investigative Site Recruiting Saitama,Saitama,330-8777,Japan #### Novartis Investigative Site Recruiting Yokohama,Kanagawa-ku,236-0004,Japan #### Novartis Investigative Site Recruiting Kawasaki,Kanagawa,2168511,Japan #### Novartis Investigative Site Recruiting Tsukuba,Ibaraki,3058576,Japan #### Novartis Investigative Site Recruiting Bunkyo-ku,Tokyo,113-8603,Japan #### Novartis Investigative Site Recruiting Toyoake,Aichi-ken,4701192,Japan #### Novartis Investigative Site Recruiting Ōta-ku,Tokyo,143 8541,Japan #### Novartis Investigative Site Recruiting Fuchū,Tokyo,183-0003,Japan #### Novartis Investigative Site Recruiting Ōmura,Nagasaki,856-8562,Japan #### Novartis Investigative Site Recruiting Nagasaki,Nagasaki,852-8501,Japan #### Novartis Investigative Site Recruiting Tsu,Mie-ken,514-8507,Japan #### Novartis Investigative Site Recruiting Kurume,Fukuoka,830-8543,Japan #### Novartis Investigative Site Recruiting Kurume,Fukuoka,830-0011,Japan #### Novartis Investigative Site Recruiting Ōbu,Aichi-ken,474 8710,Japan #### Novartis Investigative Site Recruiting Akita,010-8543,Japan #### Novartis Investigative Site Recruiting Hamamatsu,Shizuoka,430-8558,Japan #### Novartis Investigative Site Recruiting Hidaka,Saitama,350-1298,Japan ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +81337978748](tel:+81337978748) Email: