Protocol Number; CLCZ696B1401

Not Applicable

• Conditions: Chronic Heart Failure

• Registration Number: JPRN-jRCT2031200432
• Lead Sponsor: Sugimoto Toshiya

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate the safety of Entresto in chronic heart failure patients [ Time Frame: Up to 52 weeks ]<br>- EAIR of hypotension, hyperkalemia, renal impairment and dehydration will be collected.<br>- 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 Outcome Measures

Name	Time	Method
1.To evaluate the impact of risk factors [ Time Frame: Up to 52 weeks ]<br>-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<br>2.To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs [ Time Frame: Up to 52 weeks ]<br>3.EAIR for each of the clinical events [ Time Frame: Up to 52 weeks ]<br>4.Kaplan-Meier curve for each of the clinical events [ Time Frame: Up to 52 weeks ]<br>5.Total frequency of hospitalization due to heart failure [ Time Frame: Up to 52 weeks ]<br>6.To investigate data on the administration of Entresto in clinical use [ Time Frame: Up to 52 weeks ]