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

Recruiting

• Conditions: Pediatric Chronic Heart Failure

• Registration Number: NCT06659393
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-26
• Study Start: 2024-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Primary Completion: 2027-11-30
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration	one year	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.

Secondary Outcome Measures

Name	Time	Method
Occurrence of events related to hypotension, hyperkalemia, renal impairment/renal failure, and dehydration by the risk factors	one year	To investigate the impact of risk factors on the occurrence of hypotension, hyperkalemia, renal impairment/renal failure, and dehydration as safety specifications.
Occurrence of the accidental administration of the capsule-shaped container (Granules for Pediatric)	one year	To confirm the occurrence status of the accidental administration of the capsule-shaped container (Granules for Pediatric).
Occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions	one year	To confirm the occurrence of adverse events, SAEs, adverse drug reactions, and serious adverse drug reactions.
Administration status of Entresto during the observation period	one year	To confirm the administration status of Entresto used in actual clinical settings.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Toyama, Japan