NCT06659393Recruiting
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)
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 23 Oct 2024
- Start date
- 19 Dec 2024
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Heart failure
- NCT number
- NCT06659393
What you commit to
- Study type: Observational
- Planned participants: 30
- From 19 Dec 2024 to the primary completion date, 30 Nov 2027
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received drugs containing the same ingredient as Entresto (including investigational products and drugs for post-marketing clinical study)
- 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
Who the study is looking for
- Written informed consent by a legally acceptable representative must be obtained before the start of treatment with Entresto.
- Patients who received Entresto for the first time under the indication of chronic heart failure
- Pediatric patients aged 1 to \< 18 years old at the start of treatment with Entresto
Age in the registry: 1 year to 17 years · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.