Prospective Observational Study of the Sacubitril-Valsartan Treatment Effectiveness.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology.
研究概览
简要总结
The aim of this prospective study is to demonstrate if there is any difference in the treatment response to Sacubitril-Valsartan depending on the ventricular disfunction ethiology in patients with severe systolic disfunction heart failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients older than 18 years old.
- •Ejection fraction (EF) ≤ 40%.
- •Treated with optimal medical treatment for at least 3 months and remained in functional class II, III or IV.
- •Patients with ischemic or non ischemic etiology.
排除标准
- •Patients with enolic etiology.
- •Patients with any contraindication for taking Sacubitril-Valsartan.
- •Patients with EF >40%.
研究组 & 干预措施
Sacubitril-Valsartan cohort
Patients with severe systolic disfunction (left ventricle ejection fraction<40%) heart failure that remain functional class II, III or IV after at least 3 months of optimal treatment and after being evaluated by the cardiologist by doing an echocardiography, blood test and clinical evaluation, start Sacubitril-Valsartan treatment.
干预措施: Sacubitril-Valsartan (Drug)
结局指标
主要结局
Difference in the treatment response to Sacubitril-Valsartan depending on the ventricular dysfunction etiology.
时间窗: Up to 6 months after the beginning of the Sacubitril-Valsartan treatment
Verify if there is any difference in the response to the treatment with Sacubitril-Valsartan depending on the ventricular dysfunction etiology, ischemic or non-ischemic (idiopathic/familiar,toxic, volume overload,etc) excluding enolic, of patients with severe systolic heart failure.
次要结局
- Determine the microRNA genetic profile in heart failure.(Up to 6 months after the beginning of the Sacubitril-Valsartan treatment)