A safety study of sacubitril/valsartan in Japanese pediatric patients with heart failure due to systemic left ventricle systolic dysfunction who have completed CLCZ696B2319E1 study

JRCT ID: jRCT2041230115

Registered date:05/12/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure
• Date of first enrollment: 04/12/2023
• Target sample size: 8
• Study type: Interventional
• Intervention(s): All subject will receive oral administration of LCZ696

Outcome(s)

• Primary Outcome: Adverse Events

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 18age old
• Gender: Both

Include criteria

- Signed informed consent
- Completed PANORAMA-HF OLE study and safety enrolled

Exclude criteria

- Permanently discontinued the study treatement during PANORAMA-HF OLE study
- Renal vascular hypertension (including renal artery stenosis)
- History of angioedema
- Having patients or legal guardians who do not give consent or allow the child to give assent, or inability of patient or the parents/legal guardians to follow instructions or comply with follow-up procedures
- Any medical condition(s) that may put the patient at risk in the Investigator's opinion or that the Investigator deems unsuitable for the study

Related Information

• Primary Sponsor: Hirano Takamitsu
• Secondary ID(s): NCT06149104