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Completed

NCT Number: NCT04781881

Special Drug Use Surveillance for Entresto Tablets

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

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Key information

Conditions

Chronic Heart Failure

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Ichinomiya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entresto

Drug

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

Primary outcomes

  1. To evaluate the safety of Entresto in chronic heart failure patients

    Time frame: 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 outcomes

  1. To evaluate the impact of risk factors

    Time frame: 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

  2. To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs

    Time frame: 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

  3. EAIR for each of the clinical events

    Time frame: 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

  4. Kaplan-Meier curve for each of the clinical events

    Time frame: Up to 52 weeks

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

  5. Total frequency of hospitalization due to heart failure

    Time frame: Up to 52 weeks

    Total frequency of hospitalization due to heart failure will be collected

  6. To investigate data on the administration of Entresto in clinical use

    Time frame: Up to 52 weeks

    Data on Entresto administration will be collected

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Special Drug Use Surveillance for Entresto Tablets (Chronic Heart Failure, CLCZ696B1401)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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