Suspended

LOCATE-HFAdherence to New Onset Entresto® (Sacubitril/Valsartan) in Chronic Heart Failure Patients - A Prospective Cohort Study

Study Aim

This study aims to observe the percentage of chronic heart failure patients who report a high adherence score to the medication Entresto® (Sacubitril/Valsartan) at the end of the study, using a measurement called the MARS-5 Score.

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Cardiovascular Diseases

+ Heart Diseases

+ Heart Failure

From 18 to 99 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: May 2023

See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 15, 2023

Actual date on which the first participant was enrolled.

This study focuses on understanding how well patients with chronic heart failure stick to their medication regimen for Entresto® (Sacubitril/Valsartan) in a real-world setting. The research aims to assess the level of adherence to this medication, which is crucial for managing heart failure effectively. The study involves patients who are just starting with Entresto® and will last up to about 30 weeks per patient. During this period, patients will have approximately three visits: a baseline visit, a visit between week 1 and 12, and a visit between week 13 and 30. The primary outcome of the study is to measure the percentage of patients who report a high adherence to Entresto®, defined by a score of 80% or more on the MARS-5 questionnaire. This questionnaire consists of five questions that assess how often patients miss or alter their doses, with scores ranging from 5 to 25 points. These scores are then converted into a percentage, with a lower score indicating better adherence.

Official TitleReaL wOrld, pharmaCy-assessed Adherence to New onseT Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure - a Prospective Cohort Study (LOCATE-HF)

NCT05870709

Principal SponsorNovartis Pharmaceuticals

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Failure

Criteria

4 inclusion criteria required to participate

Patients with first ambulatory sacubitril/valsartan prescription at screening

Internet enabled device / smartphone (patient or affiliate)

≥ 18 years of age

Written informed consent to participate in the study

3 exclusion criteria prevent from participating

Depression-related medication, depression-related comorbidities (patient-reported)

Patients with unstable acute complications or with an advanced illness likely to interfere with participation in this trial as judged by the enrolling pharmacist

Simultaneous participation in any interventional trial or simultaneous participation in another Novartis-sponsored non-interventional study with sacubitril/valsartan

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers