Actively Recruiting
Safety Study of Entresto Tablets and Granules in Children and Teens with Chronic Heart Failure One-Year Observation of Real-World Use in Pediatric Patients
Led by Novartis Pharmaceuticals · Updated on 2026-04-13
30
Participants Needed
28
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the safety of Entresto Tablets and Granules in children with chronic heart failure. The study is conducted across multiple centers and observes pediatric patients in real-world clinical settings in Japan. The goal is to monitor safety-related events and understand risk factors during up to one year of treatment. Participants receive Entresto, a specified drug used to treat chronic heart failure, and the study carefully tracks how the medication is administered, including any accidental use of the granule form in capsule-shaped containers. The study is non-interventional and centrally enrolled, focusing on children aged 1 to under 18 years old, with a total observation period lasting 52 weeks. During the study, researchers will monitor for events like low blood pressure, high potassium levels, kidney problems, and dehydration. They will also document any adverse reactions and how Entresto is used throughout the year. The study involves ongoing safety assessments to ensure thorough observation of participants health over the full duration.
CONDITIONS
Brief Title
Entresto Tablets and Granules for Pediatric Specified Drug-use Survey (Pediatric Chronic Heart Failure)
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
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