Effect of Dapagliflozin on Left Ventricular Remodeling in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Left ventricular remodeling
研究概览
简要总结
The overall hypothesis of the study is that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction.
详细描述
In patients with heart failure, with or without diabetes, SGLT2i have shown to decrease remodeling. However, this has not been tested in patients following an acute myocardial infarction.
Acute myocardial infarction is serious condition with increasing incidence across the world. Following treatment, a reasonable amount of patients develop remodeling of the left ventricle, which is associated with worse prognosis. This occurs despite patients are treated with GDMT.
Dapagliflozin is an SGLT2i with biological plausibility to decrease left ventricular remodeling following acute myocardial infarction. In the present study, researchers will test the hypothesis that Dapagliflozin will reduce left ventricular remodeling in patients who have had a myocardial infarction (less than 7 days). This will be a randomized, single-blind, placebo controlled trial. The primary endpoint will be the change in end-diastolic and end-systolic left ventricular volumes from baseline to the end of the intervention (6 months). We will include patients with acute myocardial infarction who have been treated with primary PCI.
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, Outcomes Assessor)
盲法说明
Participants will receive either Dapagliflozin or Placebo. They will not know which arm they have been allocated to.
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
- •Acute myocardial infarction treated within the 24 hours of beginning of symptoms
- •Signed informed consent
- •SBP > 90 mmHg
- •Age >= 18 years
排除标准
- •Glomerular Filtration Rate < 30 ml/min/1.73 m
- •Pregnant or lactating woman
- •Cancer or life-threatening condition
- •Use of continuous parental inotropic agents
- •Psychiatric disease incompatible with being in study.
- •Any contraindication to MRI procedures.
- •Any other medical or physical condition considered to be inappropriate by a study physician
- •Scheduled for a PCI or CABG within the next 6 months
- •Hemodynamic unstability
- •Currently on any SGLT2i
- •One or more episodes of severe hypoglicemia
- •Acute urinary or genital infection
研究组 & 干预措施
Dapagliflozin
Dapagliflozin 10 mg PO QD
干预措施: Dapagliflozin (Drug)
Control
Placebo PO QD
干预措施: Placebo (Drug)
结局指标
主要结局
Left ventricular remodeling
时间窗: 6 months
Changes in end-diastolic and end-systolic left ventricular volumes
次要结局
- Quality of life assessed with KCCQ(6 months)
- Natriuretic peptides(6 months)
研究者
Eduardo Almeida Gutiérrez
MD
Instituto Mexicano del Seguro Social