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 Preserved Ejection Fraction (HFpEF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,988
- 试验地点
- 610
- 主要终点
- Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
研究概览
简要总结
This is a study in adults with chronic heart failure. People with chronic heart failure may need to be hospitalised for their condition. Some people with chronic heart failure may eventually die from their condition. The purpose of the study is to find out whether a medicine called empagliflozin lowers the chances of patients having to go to hospital for heart failure and whether it improves their survival. The study is open to patients with a type of chronic heart failure called chronic heart failure with preserved ejection fraction.
Participants stay in the study until researchers have enough information about how effective empagliflozin is. It is expected that participants who enter at the very beginning of the enrolment period may be in the study for over 3 years, while participants who enter near the end of the enrolment period may be in the study for less than 2 years. The participants are put into 2 groups. It is decided by chance who gets into which group. One group gets empagliflozin tablets every day and the other group gets placebo tablets every day. Placebo tablets look like empagliflozin tablets but contain no medicine.
Participants visit the doctors regularly. During these visits, the doctors collect information about the participant's health. The doctors want to know how many patients had to go to hospital because of heart failure or who died from cardiovascular disease.
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
10 mg Empagliflozin
干预措施: Empagliflozin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
时间窗: From randomization until completion of the planned treatment phase, up to 1403 days.
Failure with preserved Ejection Fraction (HFpEF). The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = 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.
次要结局
- Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)(From randomization until completion of the planned treatment phase, up to 1403 days.)
- Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52(At baseline and at week 12, week 32 and week 52.)
- Occurrence of All-cause Hospitalisation (First and Recurrent)(From randomization until completion of the planned treatment phase, up to 1403 days.)
- eGFR (CKD-EPI) cr Slope of Change From Baseline(At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.)
- Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr(From randomization until completion of the planned treatment phase, up to 1403 days.)
- Time to First Adjudicated Hospitalisation for Heart Failure (HHF)(From randomization until completion of the planned treatment phase, up to 1403 days.)
- Time to Adjudicated Cardiovascular (CV) Death(From randomization until completion of the planned treatment phase, up to 1403 days.)
- Time to All-cause Mortality(From randomization until completion of the planned treatment phase, up to 1403 days.)
- Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM(From randomization until completion of the planned treatment phase, to 1403 days.)