The Effects of Sacubitril/Valsartan on the Heart Functions

Drug Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830814
• Other study ID #: YIG01201901
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: February 2019
• Source: The Young Investigator Group of Cardiovascular Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Effect

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Young Investigator Group of Cardiovascular Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two dimensional left ventricular ejection fraction	Two dimensional ejection fraction is measured as baseline and after 3 months follow-up	3 months
Primary	Three dimensional left ventricular ejection fraction	Three dimensional ejection fraction is measured as baseline and after 3 months follow-up	3 months
Secondary	Two dimensional left ventricular volumes	Two dimensional left ventricular volumes are measured as baseline and after 3 months follow-up	3 months
Secondary	Three dimensional left ventricular volumes	Three dimensional left ventricular volumes are measured as baseline and after 3 months follow-up	3 months