Impact of Sacubitril/Valsartan on Quality of Life and Mortality of CKD vs Non-CKD in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire
研究概览
简要总结
The two primary goals of it's management are preventing further disease progression(mortality,hospitalizations and deterioration of left ventricular function)and alleviating patient suffering
详细描述
Heart failure (HF) is emerging as an epidemic in 3rd world countries. Despite significant therapeutic advances, patients with chronic heart failure remain at high risk for HF progression and death. The two primary goals of its management are preventing further disease progression(mortality, hospitalizations and deterioration of left ventricular function)and alleviating patient suffering.Sacubitril /valsartan (previously known as LCZ696) is a first-in-class medicine that contains a neprilysin (NEP )inhibitor(sacubitril) and an angiotensin II receptor blocker (valsartan). NEP is an endopeptidase that metabolizes different vasoactive peptides including natriuretic peptides, bradykinin and Ang -II. In consequence, its inhibition increases mainly the levels of both natriuretic peptides (promoting diuresis, natriuresis and vasodilation) and Ang- II whose effects are blocked by the angiotensin receptor blocker, valsartan (reducing vasoconstriction and aldosterone release).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with heart failure (NYHA class II-IV).
- •LV EF(less than or equal to 40%).
- •eGFR (more than 30 ml/min /1.73m2).
排除标准
- •Symptomatic hypotension.
- •eGFR<30 ml/min/1.73m2 .
- •Serum potassium >5.2mmol/L
研究组 & 干预措施
Observational
Sacubitril/valsartan is a combination of a neprilysin inhibitor, sacubitril and an angiotensin II receptor blocker, valsartan.
The recommended starting dose is one 49/51 mg (sacubitril/valsartan) tablet twice-daily. Double the dose of Sacubitril/valsartan after 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient.
Reduce the starting dose to 24/26 mg (sacubitril/valsartan) twice-daily for:
- Patients not currently taking an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents.
- Patients with severe renal impairment (CrCl less than 30 ml/min)
- Patients with moderate hepatic impairment. (Child Pugh B) Double the dose of Sacubitril/valsartan every 2 to 4 weeks to the target maintenance dose of 97/103 mg (sacubitril/valsartan) twice-daily, as tolerated by the patient
干预措施: Sacubitril / Valsartan Oral Tablet (Drug)
结局指标
主要结局
Assess the result on the quality of life through Kansas city cardiomyopathy Questionnaire
时间窗: 1 year
comparison of the quality of life questionnaire before and after the treatment of sacubitril/ valsartan
Analyze the result on mortality of heart failure patients through Kansas city cardiomyopathy Questionnaire
时间窗: 1 year
Improvement in mortality of heart failure patients after taking treatment of sacubitril/ valsartan.
次要结局
- Incidence of acute kidney injury after taking angiotensin receptor neprilysin inhibitor(1 year)