Effect of Ertugliflozin on NT-proBNP and Cardiac Function After Acute Myocardial Infarction in Patients With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded Endpoint (PROBE) Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 476
- 试验地点
- 1
研究概览
简要总结
This prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluates the efficacy of early ertugliflozin initiation (10 mg daily) compared to standard care alone on cardiac function in 476 adult patients with type 2 diabetes mellitus (T2DM) following a first acute myocardial infarction (AMI). The study is supported by scientific rationale suggesting potential effects of ertugliflozin on cardiac resident macrophages in the heart after myocardial infarction.The primary objective is to assess the change in NT-proBNP levels from baseline to 26 weeks, while secondary endpoints explore echocardiographic parameters (such as LVEF and LAVi) and metabolic indices including blood ketone levels, HbA1c, and body weight. Eligible participants are randomized in a 1:1 ratio within 72 hours of AMI onset and followed for a total of 30 weeks to monitor both efficacy outcomes and safety events, with a specific focus on serious adverse events like severe hypoglycemia, genital infections, and ketoacidosis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Clinically confirmed type 2 diabetes mellitus (T2DM)
- •First acute myocardial infarction (AMI) with planned randomization within 72 hours of AMI onset
- •Ability to understand and voluntarily sign written informed consent
排除标准
- •Type 1 diabetes mellitus or history of diabetic ketoacidosis
- •Gestational diabetes, pregnancy, or breastfeeding
- •End-stage renal disease (ESRD), dialysis, or prior kidney transplantation
- •Use of any SGLT2 inhibitor within 4 weeks prior to enrollment
- •Hemodynamic instability or investigator judgment that participation is not in the patient's best interest
- •Systolic blood pressure < 90 mmHg at enrollment or requiring vasopressors to maintain blood pressure
研究组 & 干预措施
Control
Standard AMI pharmacotherapy alone for 26 weeks, without Ertugliflozin or any placebo.
干预措施: Standard AMI Care (Other)