Impact of Sacubitril/Valsartan on LV Diastolic Function in HFrEF

NCT ID: NCT07157527

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-06-01
• Study Completion Date: 2027-12-30

Brief Summary

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.

Detailed 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.

Conditions

Left Ventricular Diastolic Function

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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.

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hebba Awd

resident at the Cardiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Li J, Song Y, Chen F. Evaluating the impact of Sacubitril/valsartan on diastolic function in patients with heart failure: A systematic review and meta-analysis. Medicine (Baltimore). 2024 May 10;103(19):e37965. doi: 10.1097/MD.0000000000037965.

Reference Type: BACKGROUND

PMID: 38728489 (View on PubMed)

Other Identifiers

Sacubitril/Valsartan on LV

Identifier Type: -

Identifier Source: org_study_id