Safety of Entresto for children with chronic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +81337978748

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.