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Terminated due to business decision
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sacubitril/valsartan | patient with a first ambulatory sacubitril/valsartan prescription |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sacubitril/valsartan | Other | There is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled. |
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with pre-defined comorbidities | Number of patients with pre-defined comorbidities will be collected | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with heart failure who pick up their first ambulatory sacubitril/valsartan prescription in approximately 50 participating pharmacies all over Germany.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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| Up to 30 weeks |
| Number of deaths | Number of deaths will be collected | 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 | Baseline |
| Number of patients by reason for initiation of sacubitril/valsartan | 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 | 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) | 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 | 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 |