Improvement of Left Ventricular Ejection Fraction in ICD Patients Undergoing Therapy With Sacubitril/Valsartan and Potential Impact on ICD Implant Rates for Primary Prevention of Sudden Cardiac Death (SAVE-ICD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Improvement in left ventricular ejection fraction
研究概览
简要总结
The study is aimed to evaluate the improvement of the left ventricular volumes and of the left ventricular ejection fraction in a population of ICD patients with heart failure and left ventricle systolic dysfunction undergoing therapy with Sacubitril/Valsartan (according to current Guidelines), during a 6-month follow-up.
详细描述
Consecutive, unselected patients with heart failure and left ventricle systolic dysfunction, carrying a single-chamber or a bicameral implantable cardioverter defibrillator (ICD) for primary prevention of sudden death, undergoing therapy with Sacubitril/Valsartan (according to current Guidelines) will be enrolled in the study. A two-dimensional echocardiogram with evaluation of left ventricular end-diastolic volume, left ventricular end-systolic volume, and left ventricular ejection fraction will be performed, according to standard clinical practice, at the beginning of the observation, and at a 6-month follow-up. The improvement of the left ventricle volumes and of the left ventricular ejection fraction will be evaluated.
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
- •heart failure
- •left ventricular systolic dysfunction
- •carrying a single-chamber or a bicameral implantable cardioverter defibrillator implanted for primary prevention of sudden death
- •undergoing therapy with Sacubitril/Valsartan according to current Guidelines
排除标准
- •age <18 years
结局指标
主要结局
Improvement in left ventricular ejection fraction
时间窗: at enrollment and at 6 months of follow-up
Difference between the ejection fraction observed at baseline and that observed at 6 months of follow-up
次要结局
- Reduction in left ventricle volumes(at enrollment and at 6 months of follow-up)
