A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 17,200
- 试验地点
- 11
- 主要终点
- Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening nephropathy.
研究概览
简要总结
The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure.
Patients who are prescribed either empagliflozin or dapagliflozin, as part of daily clinical practice at the participating sites, will be included in the study. Treatment will be randomized automatically through the electronic health record software in clusters defined by time of day.
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
盲法说明
Treatment assignment will be blinded to the statistician analysing the trial data.
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
- •Adults aged 18 years or more
排除标准
- •Incapabability of giving informed consent
- •Withdrawal of informed consent
研究组 & 干预措施
Empagliflozin 10 MG
Head-to-head comparator
干预措施: Empagliflozin 10 MG (Drug)
Dapagliflozin 10 MG
Head-to-head comparator
干预措施: Dapagliflozin 10 MG (Drug)
结局指标
主要结局
Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening nephropathy.
时间窗: Up to 24 months
Incident or worsening nephropathy is defined as: * A sustained decrease in estimated glomerular filtration rate (eGFR) of ≥40% from baseline * A sustained decrease in eGFR of ≤10 per minute per 1.73 m2 * Initiation of dialysis * Kidney transplantation
次要结局
- All-cause mortality(Up to 24 months)
- Hospitalization for heart failure(Up to 24 months)
- Hospitalization for myocardial infarction(Up to 24 months)
- Hospitalization for ischemic stroke(Up to 24 months)
- Incident or worsening nephropathy(Up to 24 months)
- Hospitalization for coronary revascularization(Up to 24 months)
- Hospitalization for unstable angina(Up to 24 months)
研究者
Daniel Mølager Christensen
Investigator
Herlev and Gentofte Hospital