Belgian Cohort Study Entresto | FAIR Healthdata

Belgian Cohort Study Entresto

Study Protocol: “Real World Evidence (RWE) for Entresto in the context of an article 81 procedure”

N.V. Novartis Pharma S.A.

Data and Resources

Belgian Cohort Study Entrestojson Download

Field	Value
Modified	2020-09-04
Release Date	2019-07-31
Identifier	e9430a2e-4fb1-4a86-aec3-86e288a573ac
License	License Not Specified
Public Access Level	Public

Protocol

Protocol
Full title of the project	Belgian Cohort Study Entresto

General information

General information
Project description	Study Protocol: “Real World Evidence (RWE) for Entresto in the context of an article 81 procedure” N.V. Novartis Pharma S.A.

Medical condition or disease under investigation
Medical condition(s) being investigated	Heart failure with reduced ejection fracture

Objective of the project
Main objective of the project	The main objectives of this study are: to describe the population characteristics of patients treated with Entresto for HFrEF in Belgium for the period 11/2016 until 1/2018; to estimate the hospitalization rates (all cause) of patients treated with Entresto for HFrEF in Belgium for the period 11/2016 until 1/2018; to estimate the mortality (all cause) rates of patients treated with Entresto for HFrEF in Belgium for the period 11/2016 until 1/2018.
Secondary objectives of the project	The secondary objectives of this study are: to estimate the hospitalization rates for heart failure patients treated with Entresto for HFrEF in Belgium for the period 11/2016 until 1/2018; to estimate the cardiovascular mortality among patients treated with Entresto for HFrEF in Belgium for the period 11/2016 until 1/2018; data (main & secondary objectives) specific to age-group > 75 years data (main & secondary objectives) specific to New York Heart Association Functional Classification (NYHA) class III and IV