Impact of Sacubitril/Valsartan on LV Diastolic Function in HFrEF

Assiut University

Status: Begins enrollment in 3 months

Conditions: Left Ventricular Diastolic Function

Study type: Observational

Funder types: Other

Identifiers

NCT07157527

Sacubitril/Valsartan on LV

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 1 patient group

Patients receive sacubitril/valsartan as part of guideline-directed medical therapy

Description:

Patients receive sacubitril/valsartan as part of guideline-directed medical therapy. Echocardiographic, clinical, ECG, and laboratory evaluations are performed before initiation and after 6 months of continuous ARNI treatment to assess changes in cardiac function and clinical status.