Special Drug Use Surveillance for Entresto Tablets

Novartis Pharmaceuticals688 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

688

Conditions

Chronic Heart Failure

Interventions

EntrestoDRUG

There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility

Sex: ALLMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (121)

Outcomes

Primary Outcomes

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

Time frame: Up to 52 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Up to 52 weeks

Kaplan-Meier curve for each of the clinical events

Kaplan-Meier estimate of cumulative failure rate(%) will be collected

Time frame: Up to 52 weeks

Total frequency of hospitalization due to heart failure

Total frequency of hospitalization due to heart failure will be collected

Data from ClinicalTrials.gov

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Novartis Investigative Site

Ichinomiya, Aichi-ken, Japan

Novartis Investigative Site

Ichinomiya, Aichi-ken, Japan

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Nishio, Aichi-ken, Japan

Novartis Investigative Site

Ōbu, Aichi-ken, Japan

Novartis Investigative Site

Yatomi, Aichi-ken, Japan

Novartis Investigative Site

Funabashi, Chiba, Japan

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Sakura, Chiba, Japan

Novartis Investigative Site

Yachiyo, Chiba, Japan

...and 111 more locations