Safety of Entresto for children with chronic heart failure

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

This study is testing how safe Entresto is for kids aged 1 to under 18 who are starting treatment for chronic heart failure.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 1 Year to 17 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 28 sites (Ōbu, Aichi-ken and 27 other locations)
• Trial ID: NCT06659393 on ClinicalTrials.gov

What this trial studies

This multicenter, single-arm, non-interventional survey investigates the safety of Entresto Tablets and Granules in pediatric patients with chronic heart failure. The study will observe participants for up to 52 weeks to collect data on safety specifications and any related adverse events in real-world clinical settings. It aims to identify risk factors associated with these events and monitor the administration of Entresto, including any accidental use of capsule-shaped containers. The focus is on pediatric patients aged 1 to under 18 years who are starting treatment with Entresto for the first time.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 1 to under 18 years who are beginning treatment with Entresto for chronic heart failure.

Not a fit: Patients who have previously received Entresto or have contraindications to its use will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data that may improve treatment options for children with chronic heart failure.

How similar studies have performed: While this approach is observational and focuses on safety, similar studies have shown success in gathering important safety data for pediatric medications.

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

Where this trial is running

Ōbu, Aichi-ken and 27 other locations

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

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Pediatric Chronic Heart Failure