Effect of Sodium Glucose Co-transporter 2 Inhibitors on Left Atrial Remodeling in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- follow-up and evaluation of LA remodeling in patients with type-2 diabetes mellitus ( T2DM) before and after treatment with SGLT2 inhibitors
研究概览
简要总结
To evaluate and follow-up left atrial volume, diastolic function by 2D echocardiography and left atrial strain parameters using speckle-tracking echocardiography in patients with type 2 diabetes mellitus (T2DM) before and after treatment with SGLT2 inhibitors
详细描述
Diabetes mellitus (DM) is a chronic metabolic disorder that significantly increases cardiovascular morbidity and mortality. Among the earliest manifestations of diabetic heart disease is subclinical cardiac dysfunction, which includes left atrial (LA) remodeling and impaired LA function.
LA remodeling encompasses changes in atrial size, geometry, wall stress, and mechanical function, and serves as an early marker of diastolic dysfunction and elevated left ventricular (LV) filling pressures.
These changes are key contributors to the development of heart failure, particularly heart failure with preserved ejection fraction (HFpEF)[4]and is closely associated with an increased risk of atrial fibrillation (AF).
Conventional echocardiographic parameters often fail to detect early LA dysfunction. Recent advances have highlighted left atrial strain-measured via speckle tracking echocardiography (STE)-as a more sensitive and early marker of LA dysfunction . LA strain assessment, especially during the reservoir, conduit, and contraction phases, provides insights into atrial compliance, stiffness, and overall diastolic function, often preceding structural alterations.
Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors are a class of antihyperglycemic agents that have demonstrated significant cardiovascular benefits in clinical trials. Beyond glycemic control, these agents have been linked to favorable cardiac remodeling, improved diastolic function, and reduced filling pressures. However, their impact on LA function, particularly as assessed by strain parameters, remains underexplored
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed T2DM on antidiabetic medication not including SGLT2 inhibitors.
- •HbA1c ≤ 7%.
- •Age 40-75 years.
- •Sinus rhythm.
- •Informed consent obtained
排除标准
- •History of atrial fibrillation or flutter.
- •Patients treated with SGLT2 inhibitors.
- •Severe mitral valve regurgitation or stenosis.
- •Previous myocardial infarction.
- •Previous percutaneous coronary intervention(PCI) or coronary artery bypass grafting (CABG).
- •LV Ejection fraction <50% .
- •Severe renal impairment (eGFR < 30 mL/min/1.73 m²)
- •Uncontrolled hypertension (BP > 160/100 mmHg)
- •Inadequate echocardiographic windows or incomplete data
结局指标
主要结局
follow-up and evaluation of LA remodeling in patients with type-2 diabetes mellitus ( T2DM) before and after treatment with SGLT2 inhibitors
时间窗: 6 months follow-up
The study aims evaluation and follow-up of Left Atrial Strain Parameters assessed by Speckle-Tracking Echocardiography (STE) before and after treatment with SGLT2 inhibitors in patients with type-2 diabetes mellitus at Baseline and 6 months follow-up . Left atrial strain will be measured using 2D speckle-tracking echocardiography, including reservoir strain (%), conduit strain (%), and contraction strain (%)
次要结局
未报告次要终点
研究者
Abanoub Fayoumy Shawky
Doctor
Assiut University