The Effects of Sacubitril/Valsartan on the Heart Functions

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.

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Key information

Conditions

Drug Effect Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Procedure

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

Primary outcomes

Two dimensional left ventricular ejection fraction

Time frame: 3 months

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

Time frame: 3 months

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

Secondary outcomes

Two dimensional left ventricular volumes

Time frame: 3 months

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

Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

The Young Investigator Group of Cardiovascular Research

Network

Registry information

Official study title

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

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2018
First posted: Feb 5, 2019
Registry last updated: Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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