The Effects of Sacubitril/Valsartan on the Heart Functions

NCT03830814 | Completed

• 1 other identifier: YIG01201901
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Drug Effect

Keywords

Sacubitril/Valsartan; Heart Failure; Ejection Fraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Two dimensional left ventricular volumes

  3 months

• Three dimensional left ventricular volumes

  3 months

Study Arms (1)

Cases

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

Interventions

Echocardiography PROCEDURE

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

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One hundred patients with heart failure with reduced ejection fraction (HRrEF) who have indications for the use of sacubitril/valsartan as recommended by recent guidelines were prospectively enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Young Investigator Group of Cardiovascular Research: lead

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 5, 2019
• Study Start: January 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: February 5, 2019

Record last verified: 2019-02