Evaluation of the Effect of Dapagliflozin on Cardiac Remodeling in Post Myocardial Infarction Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction
研究概览
简要总结
A prospective, randomized, controlled study will be conducted at Clinical Cardioglogy department, Ain Shams University Hospitals, assessing the efficacy and tolerability of SGLT2 inhibitors (dapagliflozin) addition on the clinical outcome and cardiac remodeling markers of post myocardial infarction (MI) diabetic patients
详细描述
All patients presenting to the Clinical Cardiology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
- Female or male aged >18 and < 75 years
- Diabetic post myocardial infarction patients
- First anterior STEMI with successful TIMI-3 flow
- STEMI within 12 hrs of onset of chest pain
- creatine clearance ≥60 mL/min
- HbA1c between 6.5% and 12.0%
Exclusion criteria:
- Cardiogenic shock on admission
- Multivessel disease on admission
- Mechanical complications e.g. mitral regurge on admission
- Life threatening arrhythmia on admission
- Hemodynamic instability on admission
- Diagnosis of Type 1 diabetes mellitus
- History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
- Pregnant or breast-feeding patients
- Active participation in another clinical study
- AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
- CrCl < 60 ml/min (based on the Cockroft-Gault equation)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male aged >18 and < 75 years
- •Diabetic post myocardial infarction patients
- •First anterior STEMI with successful TIMI-3 flow
- •STEMI within 12 hrs of onset of chest pain
- •creatine clearance ≥60 mL/min
- •HbA1c between 6.5% and 12.0%
排除标准
- •Cardiogenic shock on admission
- •Multivessel disease on admission
- •Mechanical complications e.g. mitral regurge on admission
- •Life threatening arrhythmia on admission
- •Hemodynamic instability on admission
- •Diagnosis of Type 1 diabetes mellitus
- •History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
- •Active urinary infection diagnosed by clinical symptoms of urgency and frequency + lab tests
- •Pregnant or breast-feeding patients
- •Active participation in another clinical study
- •AST or ALT >3x ULN or Total bilirubin >2.5 x ULN
- •CrCl < 60 ml/min (based on the Cockroft-Gault equation)
研究组 & 干预措施
Intervention arm
30 patients will receive standard of care in addition to the SGLT2 Dapagliflozin 10 mg daily for 4 Weeks
Interventions:
Drug: Dapagliflozin 10 mg oral tablets Standard of care: Dual antiplatelet therapy, Statin, anticoagulation therapy
干预措施: Dapagliflozin 10Mg Tab (Drug)
结局指标
主要结局
Effect on ST2 (suppression of tumerogenicity 2) level in the acute phase after myocardial infarction
时间窗: 4 weeks
patients will be followed up for the whole period of the study and blood sample will be drawn at baseline and at study end to track changes in the level of ST2 (suppression of tumerogenicity 2) which is a cardiac remodeling biomarker using ELISA technique
次要结局
- Echocardiographic changes due to intervention(4 weeks)
研究者
Abdallah Heshmat
Clinical pharmacy demonstrator
Ain Shams University