Protocol Number; CLCZ696B1401

Special drug use surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031200432

Enrollment

660

Registered

2021-03-18

Start date

2021-03-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must provide written consent to cooperate in this study before the start of Entresto 2. Patients using Entresto for the first time for the following indication -Indication: chronic heart failure patients on standard of care for chronic heart failure

Exclusion criteria

Exclusion criteria: 1. Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto 2. The following patients for whom Entresto is contraindicated in the package insert Patients with a history of hypersensitivity to any of the Entresto ingredients Patients with a history of angioedema (angiotensin II receptor blockers or angiotensin converting enzyme inhibitors-induced angioedema, hereditary angioedema, acquired angioedema, idiopathic angioedema etc.) Diabetic patients on aliskiren fumarate Patients with severe hepatic impairment (Child-Pugh class C) Pregnant or possibly pregnant women

Design outcomes

Primary

Measure	Time frame
1.To evaluate the safety of Entresto in chronic heart failure patients [ Time Frame: Up to 52 weeks ] - EAIR of hypotension, hyperkalemia, renal impairment and dehydration will be collected. - EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients	—

Secondary

Measure	Time frame
1.To evaluate the impact of risk factors [ Time Frame: Up to 52 weeks ] -Subgroup analysis of EAIR (patients/100 patient-years) of hypotension, hyperkalemia, renal impairment and dehydration by risk factor will be presented EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients 2.To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs [ Time Frame: Up to 52 weeks ] 3.EAIR for each of the clinical events [ Time Frame: Up to 52 weeks ] 4.Kaplan-Meier curve for each of the clinical events [ Time Frame: Up to 52 weeks ] 5.Total frequency of hospitalization due to heart failure [ Time Frame: Up to 52 weeks ] 6.To investigate data on the administration of Entresto in clinical use [ Time Frame: Up to 52 weeks ]	—

Measure

Time frame

1.To evaluate the impact of risk factors [ Time Frame: Up to 52 weeks ] -Subgroup analysis of EAIR (patients/100 patient-years) of hypotension, hyperkalemia, renal impairment and dehydration by risk factor will be presented EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients 2.To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs [ Time Frame: Up to 52 weeks ] 3.EAIR for each of the clinical events [ Time Frame: Up to 52 weeks ] 4.Kaplan-Meier curve for each of the clinical events [ Time Frame: Up to 52 weeks ] 5.Total frequency of hospitalization due to heart failure [ Time Frame: Up to 52 weeks ] 6.To investigate data on the administration of Entresto in clinical use [ Time Frame: Up to 52 weeks ]

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Contacts

Public ContactDirect Novartis

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120003293

Outcome results