Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: sacubitril/valsartan
- Registration Number
- NCT05870709
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description sacubitril/valsartan sacubitril/valsartan patient with a first ambulatory sacubitril/valsartan prescription
- Primary Outcome Measures
Name Time Method Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study 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%.
- Secondary Outcome Measures
Name Time Method Number of patients with worsening of HF and reason for event. Up to 30 weeks Number of patients with worsening of HF and reason for event will be collected
Number of patients with pre-defined comorbidities Baseline Number of patients with pre-defined comorbidities will be collected
Number of patients by HF-treatment Baseline Number of patients by HF-treatment (ACEi, ARBs, β-blockers, MRAs, diuretics, SGLT2i) will be collected
Number of patients by reason for initiation of sacubitril/valsartan Baseline Number of patients by reason for initiation of sacubitril/valsartan will be collected
Number of all medications and products that the patient is currently taking on a regular basis Baseline number of all medications and products that the patient is currently taking on a regular basis (including HF medication) will be collected
Change from baseline in weekly patient activity and quality of life (PA & QoL) questionnaire 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).Number of deaths Up to 30 weeks Number of deaths will be collected
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) 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