Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure (LOCATE-HF)
ReaL wOrld, pharmaCy-assessed Adherence to New onseT Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure - a Prospective Cohort Study (LOCATE-HF)
Study Overview
Detailed Description
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
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
sacubitril/valsartan
patient with a first ambulatory sacubitril/valsartan prescription
|
There is no treatment allocation.
Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study
Time Frame: Visit 3, up to 30 weeks
|
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%. |
Visit 3, up to 30 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with pre-defined comorbidities
Time Frame: Baseline
|
Number of patients with pre-defined comorbidities will be collected
|
Baseline
|
|
Number of patients with worsening of HF and reason for event.
Time Frame: Up to 30 weeks
|
Number of patients with worsening of HF and reason for event will be collected
|
Up to 30 weeks
|
|
Number of deaths
Time Frame: Up to 30 weeks
|
Number of deaths will be collected
|
Up to 30 weeks
|
|
Number of patients by HF-treatment
Time Frame: Baseline
|
Number of patients by HF-treatment (ACEi, ARBs, β-blockers, MRAs, diuretics, SGLT2i) will be collected
|
Baseline
|
|
Number of patients by reason for initiation of sacubitril/valsartan
Time Frame: Baseline
|
Number of patients by reason for initiation of sacubitril/valsartan will be collected
|
Baseline
|
|
Number of all medications and products that the patient is currently taking on a regular basis
Time Frame: Baseline
|
number of all medications and products that the patient is currently taking on a regular basis (including HF medication) will be collected
|
Baseline
|
|
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Baseline, up to 30 weeks
|
It covers physical function, clinical symptoms, social function, self-efficacy and knowledge, each with different Likert scaling wording, including limitations, frequency, bother, change in condition, understanding, levels of enjoyment and satisfaction.
The score ranges from 0-100, higher scores mean a better outcome
|
Baseline, up to 30 weeks
|
|
Change from baseline in weekly patient activity and quality of life (PA & QoL) questionnaire
Time Frame: Up to 30 weeks
|
It consists of seven questions addressing physical activity and the ability to attend patient's normal life (hobbies, house work, appointments etc) within the last week. Physical activity is documented as time [min] / day of physical activity and time of doing sports [h] /week. Ability of attending normal life is ranged in five categories (I fully agree / I agree / neutral / I don't agree / I don't agree at all). |
Up to 30 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLCZ696BDE05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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