A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,730
- 试验地点
- 514
- 主要终点
- Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
研究概览
简要总结
The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.
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, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Empagliflozin
干预措施: Empagliflozin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
时间窗: From randomisation until completion of the planned treatment period, up to 1040 days.
Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier. Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
次要结局
- Number of All-cause Hospitalizations (First and Recurrent)(From randomisation until completion of the planned treatment phase, up to 1040 days.)
- Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)(From randomisation until completion of the planned treatment phase, up to 1040 days.)
- eGFR (CKD-EPI) cr Slope of Change From Baseline(Assessed at baseline, week 4, 12, 32, 52, 76, 100, 124, 148 and at end of treatment (EOT), up to 1040 days.)
- Time to First Event in Composite Renal Endpoint: Chronic Dialysis, Renal Transplant or Sustained Reduction of eGFR(CKD-EPI)cr(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Time to First Adjudicated Hospitalisation for Heart Failure (HHF)(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Time to Adjudicated Cardiovascular (CV) Death(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Time to All-cause Mortality(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Time to Onset of Diabetes Mellitus (DM)(From randomisation until completion of the planned treatment period, up to 1040 days.)
- Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52(Assessed at baseline, week 12, week 32 and week 52.)