Chronic Heart Failure
Conditions
Keywords
chronic heart failure, Entresto, Japan, sacubitril/valsartan, sacubitril valsartan sodium hydrate
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.
Interventions
DRUGEntresto
There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Kaplan-Meier curve for each of the clinical events | Up to 52 weeks | Kaplan-Meier estimate of cumulative failure rate(%) will be collected |
Countries
Japan
Outcome results
None listed