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临床试验/NCT03830814
NCT03830814已完成不适用

What Are the Effects of Sacubitril/Valsartan on the Heart Functions? Can It Increase the Ejection Fraction?

The Young Investigator Group of Cardiovascular Research0 个研究点目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
主要终点
Two dimensional left ventricular ejection fraction

研究概览

简要总结

Background:

Sacubitril/valsartan, has been found to be more beneficial than enalapril for reducing the incidences of sudden cardiac death, death from worsening heart failure (HF), and hospitalization. However, there is no prospective echocardiographic data describing the effects of sacubitril/valsartan on the heart functions and left ventricular (LV) reverse remodeling. Therefore, the aim of our study was to evaluate the effects of sacubitril/valsartan on the LV functions using two dimensional (2D), three dimensional (3D) echocardiography and the 3D strain parameters.

Methods:

In 100 patients with HF with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled. The basal 2D and 3D echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment.

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

入选标准

  • Age is more than or equal 18 years old
  • Able to provide written informed consent
  • Indicated for the use of sacubitril/valsartan as recommended by the European Society of Cardiology (ESC) heart failure guidelines 2016
  • Left ventricular ejection fraction of 40% or less

排除标准

  • Cardiac resynchronization therapy (CRT) device implantation less than 3 months prior to the start of this study or CRT implantation intentions
  • Atrial fibrillation
  • Poor echocardiographic images
  • Sacubitril/valsartan treatment intolerance during the follow-up period

结局指标

主要结局

Two dimensional left ventricular ejection fraction

时间窗: 3 months

Two dimensional ejection fraction is measured as baseline and after 3 months follow-up

Three dimensional left ventricular ejection fraction

时间窗: 3 months

Three dimensional ejection fraction is measured as baseline and after 3 months follow-up

次要结局

  • Three dimensional left ventricular volumes(3 months)
  • Two dimensional left ventricular volumes(3 months)

研究者

发起方
The Young Investigator Group of Cardiovascular Research
申办方类型
Network
责任方
Sponsor

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