The Effects of Sacubitril/Valsartan on the Heart Functions

NCT ID: NCT03830814

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-07-31

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.

Detailed Description

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Conditions

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Drug Effect

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines

Echocardiography

Intervention Type PROCEDURE

Basal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment

Interventions

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Echocardiography

Basal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Young Investigator Group of Cardiovascular Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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YIG01201901

Identifier Type: -

Identifier Source: org_study_id

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