Special Drug Use Surveillance for Entresto Tablets

Completed

• Conditions: Chronic Heart Failure
• Interventions: Drug: Entresto

• Registration Number: NCT04781881
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study Start: 2021-03-04
• Study First Posted: 2021-03-04
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 688

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Entresto	Entresto	Patients administered Entresto by prescription

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of Entresto in chronic heart failure patients	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 Outcome Measures

Name	Time	Method
To evaluate the impact of risk factors	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
To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs	Up to 52 weeks	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
EAIR for each of the clinical events	Up to 52 weeks	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
Kaplan-Meier curve for each of the clinical events	Up to 52 weeks	Kaplan-Meier estimate of cumulative failure rate(%) will be collected
Total frequency of hospitalization due to heart failure	Up to 52 weeks	Total frequency of hospitalization due to heart failure will be collected
To investigate data on the administration of Entresto in clinical use	Up to 52 weeks	Data on Entresto administration will be collected

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Yamaguchi, Japan