Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Difference in mean EF% between the treatment and control study arms
研究概览
简要总结
Patients with diabetes have poorer cardiac surgery outcomes compared with non-diabetics. Proper blood glucose management is critical to reduce the morbidity and mortality for diabetic patients after cardiac surgery.
SGLT2 inhibitors including dapagliflozin as a new diabetes drug can reduce heart failure hospitalization rates and overall cardiovascular mortality in patients with cardiovascular disease.
This study is to assess the impact of one year of treatment of SGLT2 inhibitors on cardiac function, postoperative complications and long-term cardiovascular mortality in diabetic patients undergoing cardiac surgery.
The investigators use echocardiography to evaluated cardiac function in diabetic patients during perioperative cardiac surgery.
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
- None
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
- •Age ≥ 18 years old at index date.
- •Diagnosis of Type 2 Diabetes.
- •Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
- •eGFR ≥ 60 ml/min/1.73 m
- •Patients who agree to receive treatment with SGLT2 inhibitors.
- •Patients must be on current stable hemodynamic profile , without dehydration.
排除标准
- •Diagnosis of Type 1 Diabetes.
- •eGFR < 60 ml/min/1.73 m
- •Unstable or rapidly progressive renal disease.
- •Hypersensitivity to dapagliflozin or any excipients.
- •Severe hepatic disease.
- •Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
- •Any other reason considered by a study physician to be inappropriate for inclusion.
研究组 & 干预措施
Treatment
Dapagliflozin 10 mg tablet
干预措施: Dapagliflozin 10 MG (Drug)
Control
matching placebo tablet
干预措施: Placebos (Drug)
结局指标
主要结局
Difference in mean EF% between the treatment and control study arms
时间窗: 2 year
Echocardiography is used to assess cardiac function.
Difference in NTproBNP between the treatment and control study arms
时间窗: 2 year
NT-proBNP is used to assess cardiac function.
次要结局
- Hypoglycemia(2 year)
- Rehospitalization for cardiovascular causes(2 year)
- Acute postoperative kidney injury(2 year)
- Serious postoperative infection(2 year)
- All-cause postoperative mortality(2 year)
- Duration of Hospitalization(2 year)
- Diabetic ketoacidosis(2 year)
- Lactic acidosis(2 year)
- Post operative atrial fibrillation(7 days)
研究者
Hongchang Guo
Attending doctor
Beijing Anzhen Hospital