The Effects of Sacubitril/Valsartan on the Heart Functions

Study Overview
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Brief Summary
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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.

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

Conditions
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Drug Effect

Intervention / Treatment
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* Procedure: Echocardiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines | Procedure: Echocardiography<br>* Basal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two dimensional left ventricular ejection fraction | Two dimensional ejection fraction is measured as baseline and after 3 months follow-up | 3 months | 
| Three dimensional left ventricular ejection fraction | Three dimensional ejection fraction is measured as baseline and after 3 months follow-up | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two dimensional left ventricular volumes | Two dimensional left ventricular volumes are measured as baseline and after 3 months follow-up | 3 months | 
| Three dimensional left ventricular volumes | Three dimensional left ventricular volumes are measured as baseline and after 3 months follow-up | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacubitril/Valsartan, Heart Failure, Ejection Fraction