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The Effects of Sacubitril/Valsartan on the Heart Functions

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03830814
Enrollment
100
Registered
2019-02-05
Start date
2017-01-01
Completion date
2018-07-31
Last updated
2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Effect

Keywords

Sacubitril/Valsartan, Heart Failure, Ejection Fraction

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.

Interventions

PROCEDUREEchocardiography

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

Sponsors

The Young Investigator Group of Cardiovascular Research
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Two dimensional left ventricular ejection fraction3 monthsTwo dimensional ejection fraction is measured as baseline and after 3 months follow-up
Three dimensional left ventricular ejection fraction3 monthsThree dimensional ejection fraction is measured as baseline and after 3 months follow-up

Secondary

MeasureTime frameDescription
Three dimensional left ventricular volumes3 monthsThree dimensional left ventricular volumes are measured as baseline and after 3 months follow-up
Two dimensional left ventricular volumes3 monthsTwo dimensional left ventricular volumes are measured as baseline and after 3 months follow-up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026