Effect of Empagliflozin 10 vs 25 mg on LV Remodeling in Diabetic Patients With Anterior STEMI With Reduced LVEF Who Underwent Primary PCI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- left ventricular remodeling
研究概览
简要总结
This study is investigating how the medication Empagliflozin affects the heart's structure and function in patients with heart disease. Empagliflozin is already used to treat diabetes and heart conditions, and this research aims to see if it can help improve heart remodeling, which may lead to better heart health and quality of life. Participants will receive the medication and have regular check-ups to monitor their progress. The study is carefully designed to ensure participant safety. If you have heart disease and want to learn more, please contact (hany_barsoum@med.asu.edu.eg).
详细描述
Heart disease is a leading cause of illness worldwide, and new treatments that improve heart function can have a significant impact on patient health and longevity. This research could provide valuable insights into how existing medications can be used to benefit people with heart conditions beyond their current use.
This clinical study aims to understand how Empagliflozin, a medication commonly used to treat diabetes, affects the heart's structure and function in people with heart disease. When the heart is damaged, especially on the left side (left ventricle), it can change shape and size-a process called remodeling-which may reduce how well the heart pumps blood. This study will explore whether Empagliflozin can help reverse or improve this remodeling process, potentially leading to better heart function and improved quality of life.
Participants in the study will receive Empagliflozin and undergo regular health check-ups, including imaging tests like echocardiograms, to track changes in heart structure and performance. The study is designed to carefully monitor safety and effectiveness, ensuring participants are supported throughout.
If you or a loved one has heart disease and are interested in learning more about this study, please contact [hany_barsoum@med.asu.edu.eg].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients with anterior STEMI with reduced LVEF who underwent PPCI with successful revascularization and resulting into TIMI III flow and who are receiving SGLTi for the first time.
排除标准
- •patients who did not undergo primary PCI, those treated medically or had thrombolysis
- •Non diabetic patient.
- •Diabetic patient already on SGLTi
- •STEMIs other than anterior.
- •NSTEMI patients.
- •Patients having valvular heart diseases.
- •Patients having renal impairment.
- •Patients with LV myopathies of non-ischemic origin.
研究组 & 干预措施
Empagliflozin 10 mg
Participants in this arm will receive Empagliflozin 10 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated.
干预措施: Empagliflozin 10 MG [Jardiance] (Drug)
Empagliflozin 25 mg
Participants in this arm will receive Empagliflozin 25 mg orally once daily for a duration of 6 months. The purpose is to evaluate the effect of Empagliflozin on left ventricular remodeling and cardiac function in patients with HFrEF. Standard heart failure therapy may be continued alongside the study drug as clinically indicated.
干预措施: empagliflozin (Jardiance) 25 mg (Drug)
结局指标
主要结局
left ventricular remodeling
时间窗: 6 months
change of left ventricular volumes form baseline and after 6 months
left ventricular systolic function
时间窗: 6 months
change of left ventricular ejection fraction from baseline and after 6 months
left ventricular Global Longitudinal Strain (GLS)
时间窗: 6 months
changes of GLS from baseline and after 6 months
次要结局
- Incidence of Major Adverse Cardiovascular Events (MACE)(6 months)
- Assessment of diastolic function(6 months)
- Left Atrial Strain(6 months)