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Not yet recruiting NCT07157527

Impact of Sacubitril/Valsartan on LV Diastolic Function in HFrEF

— Observational Left Ventricular Diastolic Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Left Ventricular Diastolic Function. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • Change in Left Ventricular Diastolic Function [Time frame: Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 38728489

Identifiers

NCT: NCT07157527 · Sacubitril/Valsartan on LV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗