Heart Failure
Conditions
Keywords
Heart failure, NIS, Germany, sacubitril, valsartan
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.
Interventions
OTHERsacubitril/valsartan
There is no treatment allocation. Patients with a first ambulatory sacubitril/valsartan prescription who are interested in study participation will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with pre-defined comorbidities | Baseline | Number of patients with pre-defined comorbidities will be collected |
| 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 by HF-treatment | Baseline | Number of patients by HF-treatment (ACEi, ARBs, β-blockers, MRAs, diuretics, SGLT2i) will be collected |
| Number of deaths | Up to 30 weeks | Number of deaths 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 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 |
| 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 patients by reason for initiation of sacubitril/valsartan | Baseline | Number of patients by reason for initiation of sacubitril/valsartan will be collected |
Outcome results
None listed