ReaL wOrld, pharmaCy-assessed Adherence to New onseT Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure - a Prospective Cohort Study (LOCATE-HF)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Percentage of patients who report a MARS-5 Score of ≥ 80% related to sacubitril/valsartan at the end of the study
时间窗: 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%.
次要结局
- Number of patients with worsening of HF and reason for event.(Up to 30 weeks)
- Number of patients with pre-defined comorbidities(Baseline)
- Number of patients by HF-treatment(Baseline)
- Number of patients by reason for initiation of sacubitril/valsartan(Baseline)
- Number of all medications and products that the patient is currently taking on a regular basis(Baseline)
- Change from baseline in weekly patient activity and quality of life (PA & QoL) questionnaire(Up to 30 weeks)
- Number of deaths(Up to 30 weeks)
- Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline, up to 30 weeks)