Special Drug Use Surveillance for Entresto Tablets

Study Overview
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Brief Summary
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This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.

Detailed Description
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This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved indication of chronic heart failure and to be conducted as one of the RMP-specified additional pharmacovigilance activities.

Official Title
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Special Drug Use Surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Drug: Entresto


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must provide written consent to cooperate in this study before the start of Entresto 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: Patients with a history of treatment with a drug containing the same ingredient (investigational drug or post-marketing clinical study drug) as Entresto 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

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Entresto<br>Patients administered Entresto by prescription | Drug: Entresto<br>* There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of Entresto in chronic heart failure patients | 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 | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the impact of risk factors | 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 | Up to 52 weeks | 
| To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs | A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal. An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Entresto or whose causality is not recorded | Up to 52 weeks | 
| EAIR for each of the clinical events | 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 | Up to 52 weeks | 
| Kaplan-Meier curve for each of the clinical events | Kaplan-Meier estimate of cumulative failure rate(%) will be collected | Up to 52 weeks | 
| Total frequency of hospitalization due to heart failure | Total frequency of hospitalization due to heart failure will be collected | Up to 52 weeks | 
| To investigate data on the administration of Entresto in clinical use | Data on Entresto administration will be collected | Up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Entresto, chronic heart failure, Japan, sacubitril/valsartan, sacubitril valsartan sodium hydrate