Impact of DApagliflozin on Cardiac Function Following Anterior Myocardial Infarction in Non-Diabetic Patients - DACAMI (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- A change in left ventricular ejection fraction, end-diastolic volume or left ventricular mass index assessed by transthoracic echocardiography at baseline, 4 weeks & 12 weeks post-anterior STEMI
研究概览
简要总结
Sodium glucose co-transporter 2 inhibitors (SGLT2i) proved their favorable outcomes in heart failure. However, it is still unknown if their role extent into preventing heart failure, especially after acute myocardial infarction. This study aimed at identifying if there is such role for SGLT2i.
详细描述
A notable breakthrough in the management of heart failure is the use of a class of anti-diabetic medications known as, gliflozins. Gliflozins act by inhibiting the sodium glucose co-transporter 2 (SGLT-2). This is a transmembrane protein found at the luminal border of tubular cells of the proximal convoluted tubules of the kidney. It accounts for around 90% of glucose re-absorption. Inhibiting the SGLT-2 results in better glycemic control in patient with diabetes mellitus type 2 (DMT2).
In heart failure, sodium glucose co-transporter 2 inhibitors (SGLT2i - i.e., gliflozins) were found to have a favorable cardiovascular outcome independent of their anti-glycemic effect. In patients with acute myocardial infarction, the heart function as a pump is affected & heart failure develops. In particular, patients with anterior ST-elevation myocardial infarction (STEMI) are at a higher risk of remodeling & heart failure. This is due to the cutoff in blood supply in the left anterior descending (LAD) coronary artery which supplies a great area of left ventricle.
A question that rises: is there a role for SGLT2i, & in particular dapagliflozin, in acute myocardial infarction in improving post-infarction cardiac function & preventing heart failure? especially in patients who experience Anterior ST-Elevation Myocardial Infarction (STEMI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients admitted with ECG Criteria for Anterior ST-elevation myocardial infarction according to the fourth universal definition of myocardial infarction*, ** & show echocardiographic evidence of reduced LV ejection fraction <50% & have undergone successful reperfusion by primary percutaneous coronary angiography (pPCI).
- •New ST segment elevation in contagious precordial leads consistent anatomically with the anterior wall of myocardium:
- •Men ≥ 40 years: 2 mV in leads V2-V3 &/or 1 mV in other precordial leads
- •Men <40 years: 2.5 mV in leads V2-V3 &/or 1 mV in other precordial leads
- •Women (regardless of age): 1.5 mV in leads V2-V3 &/or 1 mV in other precordial leads ** Patients with admission ECG showing DeWinter's Syndrome, Wellen Syndrome, New onset left bundle branch block, new onset right bundle branch block will also be included.
排除标准
- •Patients with Diabetes Miletus (Type 1 (DMT2), Type 1 (DMT1), secondary diabetes (e.g., endocrinopathies)
- •Patients already diagnosed with heart failure prior to this event
- •Patients on cardiotoxic chemotherapeutic medications.
- •Patients with haemoglobinopathies.
- •Patients with chronic organ damage (i.e., chronic hepatitis with MELD score >10, Stage 4 & 5 renal disease).
- •Patients already on SGLT2i.
- •Patients who will require additional anticoagulant therapy (i.e.: patients with transthoracic echocardiographic evidence of left ventricular thrombus).
- •Patients with contraindications for use of dapagliflozin including patients with severely impaired renal function (eGFR <30ml/min/1.73m2) &/OR previous history of genitourinary infections (i.e.: urosepsis, pyelonephritis & fournier's gangrene) &/OR at high risk of such infections.
研究组 & 干预措施
Intervention Group
Participants will receive Dapagliflozin 10mg once daily.
干预措施: Dapagliflozin 10mg (Drug)
Control Group
Participants will receive a glucose tab once daily.
干预措施: Glucose Tab (Drug)
结局指标
主要结局
A change in left ventricular ejection fraction, end-diastolic volume or left ventricular mass index assessed by transthoracic echocardiography at baseline, 4 weeks & 12 weeks post-anterior STEMI
时间窗: 12 weeks
Difference between both groups in the change of the above mentioned echocardiographic parameters assessed at baseline, 4 weeks \& 12 weeks post-anterior STEMI
A change in NT-proBNP levels from baseline to 12 weeks post-anterior STEMI
时间窗: 12 weeks
Difference between both groups in the change of NT-proBNP levels from baseline to 12 weeks post-anterior STEMI
次要结局
未报告次要终点
研究者
Omar Younis
Clinical Research Coordinator
National Heart Institute, Egypt