Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-10-31

Brief Summary

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This is a multicenter, non-interventional, single arm cohort study with prospective collection of primary data via pharmacists in community pharmacies to describe adherence to sacubitril/valsartan in study patients at the end of the study. Eligible patients with newly prescribed sacubitril/valsartan will be observed in pharmaceutical routine.

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Detailed Description

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The study duration will last up to about 30 weeks per patient and will consist of a approximately three visits - Baseline visit (V1), week 1-12 (V2) and week 13-30 (V3).

No exact date for visit 2 and visit 3 will be enforced, to avoid interference with usual care.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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sacubitril/valsartan

patient with a first ambulatory sacubitril/valsartan prescription

sacubitril/valsartan

Intervention Type OTHER

There is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled.

Interventions

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sacubitril/valsartan

There is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with first ambulatory sacubitril/valsartan prescription at screening
2. Internet enabled device / smartphone (patient or affiliate)
3. ≥ 18 years of age
4. Written informed consent to participate in the study

Exclusion Criteria

1. Depression-related medication, depression-related comorbidities (patient-reported)
2. Patients with unstable acute complications or with an advanced illness likely to interfere with participation in this trial as judged by the enrolling pharmacist
3. Simultaneous participation in any interventional trial or simultaneous participation in another Novartis-sponsored non-interventional study with sacubitril/valsartan

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No