Impact of Sacubitril/Valsartan on LV Diastolic Function in HFrEF

This prospective cohort study evaluates the effects of six months of sacubitril/valsartan (ARNI) therapy on left ventricular diastolic function in patients with heart failure with reduced ejection fraction (HFrEF) using transthoracic echocardiography. It aims to correlate echocardiographic parameters with clinical status and systolic function among Egyptian patients treated at two cardiology centers.

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Key information

Conditions

Left Ventricular Diastolic Function

Sex eligibility

All sexes

Study type

Observational

About this study

Heart failure remains a leading global health issue characterized by high morbidity and mortality, with a pronounced burden in Egypt due to younger patient age and prevalent comorbidities such as diabetes and hypertension. This study addresses the impact of ARNI therapy, which is established for improving systolic outcomes, on diastolic function-an underexplored aspect contributing to symptom severity and prognosis in HFrEF.

Conducted at Assiut General Hospital and Mabarra Hospital cardiology departments, the prospective cohort study enrolls adult patients (≥18 years) with HFrEF (LVEF < 35%) eligible for and initiating sacubitril/valsartan therapy. Transthoracic echocardiography assessments are performed at baseline and after six months of treatment, measuring parameters such as E/A ratio, E/e' ratio, left atrial volume index, deceleration time, and tricuspid regurgitation velocity according to ASE/EACVI guidelines.

The study also integrates clinical evaluations (NYHA class, comorbidities), ECG changes, and laboratory data. Statistical analyses include paired tests to compare changes over time, and correlations between echocardiographic and clinical/laboratory variables. Ethical approval was obtained, and patient confidentiality is assured.

This investigation aims to contribute novel insights into ARNI's effect on diastolic function in a high-risk Egyptian cohort, potentially informing optimized therapy and management of symptomatic heart failure beyond current evidence primarily focused on systolic improvements.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosed with HFrEF (LVEF < 35%)
Able to tolerate and comply with ARNI therapy
Patients on Guideline-Directed Medical Therapy (GDMT) for heart failure

Exclusion criteria

Patients with contraindication to ARNI therapy

Patients with poor echocardiographic window
Patients non-compliant with medication or follow-up
Patients with mitral significant lesion or mitral prosthesis.
Patients with atrial arrhythmia or on pacemaker

Treatment and study plan

Primary outcomes

Change in Left Ventricular Diastolic Function

Time frame: Baseline

Assessment of echocardiographic parameters of diastolic function (E/A ratio)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Sacubitril/Valsartan Therapy on Left Ventricular Diastolic Function in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF): An Echocardiographic Evaluation

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 5, 2025
Registry last updated: Sep 5, 2025

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.