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临床试验/NCT07157527
NCT07157527尚未招募不适用

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

Assiut University0 个研究点目标入组 70 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Change in Left Ventricular Diastolic Function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change in Left Ventricular Diastolic Function

时间窗: Baseline

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hebba Awd

resident at the Cardiology Department

Assiut University

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