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

Novartis Pharmaceuticals

Overview

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.

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.

Study Type

OBSERVATIONAL

Conditions

Heart Failure

Interventions

sacubitril/valsartanOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study

Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study will be collected. The MARS-5 questionnaire consists of five questions measuring non-adherence ranging from "never" (5 points) to "always" (1 points), therefore the score has a range from 5 - 25 points. This score will be transformed to a percentage score so that a patient with 5 points ("always" for all answers) scores 100% whereas a patient with 25 points ("never" for all answers) scores 0%.

Time frame: Visit 3, up to 30 weeks

Secondary Outcomes

Number of patients with pre-defined comorbidities

Number of patients with pre-defined comorbidities will be collected

Time frame: Baseline

Number of patients with worsening of HF and reason for event.

Number of patients with worsening of HF and reason for event will be collected

Time frame: Up to 30 weeks

Number of deaths

Number of deaths will be collected

Time frame: Up to 30 weeks

Number of patients by HF-treatment

Number of patients by HF-treatment (ACEi, ARBs, β-blockers, MRAs, diuretics, SGLT2i) will be collected

Time frame: Baseline

Number of patients by reason for initiation of sacubitril/valsartan

Number of patients by reason for initiation of sacubitril/valsartan will be collected

Time frame: Baseline

Number of all medications and products that the patient is currently taking on a regular basis

Data from ClinicalTrials.gov

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