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The Effects of Sacubitril/Valsartan on the Heart Functions

Completed
Conditions
Drug Effect
Interventions
Procedure: Echocardiography
Registration Number
NCT03830814
Lead Sponsor
The Young Investigator Group of Cardiovascular Research
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
CasesEchocardiographyPatients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines
Primary Outcome Measures
NameTimeMethod
Two dimensional left ventricular ejection fraction3 months

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

Three dimensional left ventricular ejection fraction3 months

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

Secondary Outcome Measures
NameTimeMethod
Two dimensional left ventricular volumes3 months

Two dimensional left ventricular volumes are measured as baseline and after 3 months follow-up

Three dimensional left ventricular volumes3 months

Three dimensional left ventricular volumes are measured as baseline and after 3 months follow-up

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