Special Drug Use Surveillance of Entresto Tablets (Hypertension)

Study Overview
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Brief Summary
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This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.

Detailed Description
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This study is a special drug use surveillance to collect information on the safety specifications under the actual clinical practice of Entresto Tablets in patients with hypertension in Japan to confirm the occurrence and timing of onset of events related to the safety specifications and investigate their risk factors.

Official Title
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Special Drug Use Surveillance of Entresto Tablets (Hypertension, CLCZ696A1402): ENLIGHT

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Entresto


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have given written consent to participate in this study before the start of treatment with Entresto Patients who used Entresto for the first time for the indication of hypertension Exclusion Criteria: Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug) The following patients for whom administration of Entresto is contraindicated in the package insert: Patients with a history of hypersensitivity to any of the ingredients of Entresto Patients who are receiving angiotensin-converting enzyme inhibitors (alacepril, imidapril hydrochloride, enalapril maleate, captopril, quinapril hydrochloride, cilazapril hydrate, temocapril hydrochloride, delapril hydrochloride, trandolapril, benazepril hydrochloride, perindopril erbumine, and lisinopril hydrate) or who discontinued these drugs within 36 hours. Patients with a history of angioedema (angioedema due to angiotensin II receptor antagonists or angiotensin converting enzyme inhibitors, hereditary angioedema, acquired angioedema, idiopathic angioedema, etc.) Patients with diabetes mellitus who are receiving aliskiren fumarate Patients with severe hepatic impairment (Child-Pugh class C) Pregnant or possibly pregnant women Patients with a history or complication of cardiac failure Patients who have been hospitalized at the start of treatment with Entresto

Ages Eligible for Study
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Minimum Age: 18 Years
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>* Other names: Entresto Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure | To investigate the safety of 52 weeks of treatment with Entresto in patients with hypertension in a real-world setting. In particular, the occurrence status of hypotension, hyperkalemia, and renal impairment/renal failure | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor | To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure | Up to 52 weeks | 
| Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure | To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure | Up to 52 weeks | 
| Change from baseline in sitting systolic blood pressure (sSBP) and sitting diastolic blood pressure (sDBP) over time | To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting | Up to 52 weeks | 
| Percentage of patients who achieved blood pressure control at each evaluation time point | To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting | Up to 52 weeks | 
| Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point | To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting | Up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Japan, hypertension, Entresto, Entresto Tablets, actual clinical practice, sacubitril/valsartan, sacubitril valsartan sodium hydrate