PAtient RegisTry Assessing Effectiveness and Safety of HEart Failure treatmeNt With LCZ696 acrOss CaNada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,009
- 试验地点
- 1
- 主要终点
- Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels
研究概览
简要总结
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
详细描述
The purpose of the study is to describe the heart failure with reduced ejection fraction (HFrEF) patient population receiving sacubitril/valsartan treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving sacubitril/valsartan as per the Canadian product label and treatment initiation within the last 3 months
- •Able to communicate with investigator
排除标准
- •Participation in a clinical trial of an investigational drug, concurrently, or within the last 30 days
- •Presence of any condition that in the opinion of the investigator, prohibits patient from participating in the trial
研究组 & 干预措施
sacubitril/valsartan
Patients diagnosed with HFrEF being treated with sacubitril/valsartan according to the Canadian product label and treatment initiation with sacubitril/valsartan within the last 3 months. The usual recommended starting dose is one tablet of 49 mg sacubitril / 51 mg valsartan taken twice daily. The target dose is one tablet of 97 mg sacubitril / 103 mg valsartan taken twice daily. Investigator/designated will document sacubitril/valsartan treatment adherence throughout the 3 years study period
干预措施: sacubitril/valsartan (Drug)
结局指标
主要结局
Rate of all-cause hospitalization or all- cause mortality in relation to NT-proBNP or BNP levels
时间窗: Up to 3 years
The primary objective is to describe baseline NT- proBNP, or BNP levels, in relation to total all- cause hospitalization or all-cause mortality in patients with HFrEF treated with sacubitril/valsartan
次要结局
- Relationship between changes in NT-proBNP and all-cause mortality(Up to 3 years)
- Percentage of patients with clinically relevant hyperkalemia(Up to 3 years)
- Relationship between changes in NT-proBNP and total all-cause hospitalization(Up to 3 years)
- Relationship between changes in NT-proBNP and renal impairment(Up to 3 years)
- Percentage of patients with clinically relevant renal impairment(Up to 3 years)
- Percentage of patients with clinically relevant symptomatic hypotension(Up to 3 years)
- Percentages of patients having a BNP or NT-proBNP level(Up to 3 years)