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临床试验/NCT03935087
NCT03935087Unknown不适用

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)

Azienda Ospedaliera Cardinale G. Panico6 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年8月1日最近更新:
适应症

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

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)

研究者

发起方
Azienda Ospedaliera Cardinale G. Panico
申办方类型
Other
责任方
Sponsor

研究点 (6)

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