An observational study in Pediatric Chronic Heart Failure, sponsored by Novartis Pharmaceuticals. Recruiting at 28 sites in Japan. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Novartis Pharmaceuticals · Observational
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.
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.
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Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
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Japanese pediatric patients with chronic heart failure using Entresto Tablets and Granules
Exclusion criteria
Patients for whom Entresto is contraindicated according to the package insert
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.
Time frame: one year
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.
Time frame: 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).
Time frame: 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.
Time frame: one year
Administration status of Entresto during the observation period
To confirm the administration status of Entresto used in actual clinical settings.
Time frame: one year
Plan to share: No
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Novartis Pharmaceuticals