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

Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure, CLCZ696F1401)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Chronic Heart Failure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +81337978748; Email: novartis.email@novartis.com

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Recruiting
    • Novartis Investigative Site
  • Fukuoka, Japan, 8128582
    • Active, not recruiting
    • Novartis Investigative Site
  • Kumamoto, Japan, 862-8505
    • Completed
    • Novartis Investigative Site
  • Okayama, Japan, 7008558
    • Recruiting
    • Novartis Investigative Site
  • Aichi-ken
    • Toyoake, Aichi-ken, Japan, 4701192
      • Recruiting
      • Novartis Investigative Site
    • Ōbu, Aichi-ken, Japan, 474 8710
      • Recruiting
      • Novartis Investigative Site
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Recruiting
      • Novartis Investigative Site
    • Kurume, Fukuoka, Japan, 830-8543
      • Recruiting
      • Novartis Investigative Site
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Recruiting
      • Novartis Investigative Site
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 3058576
      • Recruiting
      • Novartis Investigative Site
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 2168511
      • Recruiting
      • Novartis Investigative Site
  • Kanagawa-ku
    • Yokohama, Kanagawa-ku, Japan, 236-0004
      • Recruiting
      • Novartis Investigative Site
  • Mie-ken
    • Tsu, Mie-ken, Japan, 514-8507
      • Recruiting
      • Novartis Investigative Site
  • Nagasaki
    • Nagasaki, Nagasaki, Japan, 852-8501
      • Recruiting
      • Novartis Investigative Site
    • Ōmura, Nagasaki, Japan, 856-8562
      • Recruiting
      • Novartis Investigative Site
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
      • Recruiting
      • Novartis Investigative Site
    • Saitama, Saitama, Japan, 330-8777
      • Recruiting
      • Novartis Investigative Site
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 430-8558
      • Recruiting
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo Ku, Tokyo, Japan, 1138431
      • Recruiting
      • Novartis Investigative Site
    • Bunkyo Ku, Tokyo, Japan, 113-8655
      • Recruiting
      • Novartis Investigative Site
    • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Recruiting
      • Novartis Investigative Site
    • Fuchū, Tokyo, Japan, 183-0003
      • Recruiting
      • Novartis Investigative Site
    • Fuchū, Tokyo, Japan, 1838561
      • Recruiting
      • Novartis Investigative Site
    • Setagaya-ku, Tokyo, Japan, 1578535
      • Recruiting
      • Novartis Investigative Site
    • Shinagawa-ku, Tokyo, Japan, 1428666
      • Recruiting
      • Novartis Investigative Site
    • Shinjuku Ku, Tokyo, Japan, 1628666
      • Recruiting
      • Novartis Investigative Site
    • Ōta-ku, Tokyo, Japan, 143 8541
      • Recruiting
      • Novartis Investigative Site
  • Toyama
    • Toyama, Toyama, Japan, 9300194
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Japanese pediatric patients with chronic heart failure using Entresto Tablets and Granules

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration	To confirm the occurrence status up to 52 weeks of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications of Entresto administration in pediatric patients with chronic heart failure in actual clinical settings.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors	To investigate the impact of risk factors on the occurrence of hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications.	one year
Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric)	To confirm the occurrence status of the accidental administration of the capsule-shaped container (Granules for Pediatric).	one year
Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions	To confirm the occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions.	one year
Administration status of Entresto during the observation period	To confirm the administration status of Entresto used in actual clinical settings.	one year

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CLCZ696F1401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No