Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group
研究概览
简要总结
The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（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
Immediate introduction of everolimus
干预措施: Everolimus (Drug)
Delayed introduction of everolimus
delayed introduction) + Cyclosporin + steroids
干预措施: Mycophenolate mofetil + Everolimus (Drug)
结局指标
主要结局
Participants With at Least One Occurrence of Safety Composite Endpoint After 6 Months by Treatment Group
时间窗: 6 months
Comparison of 6-month cumulative incidence of safety composite endpoint (wound healing delay) related to initial transplant surgery, pleural/pericardial effusions and occurrence of acute renal insufficiency, defined as estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73 m2, between delayed everolimus arm and immediate everolimus arm
次要结局
- Partcipants With at Least One Occurrence of Each Safety Composite Endpoint Event After 6 Months by Treatment Group(6 months)
- Hazard Cox's Model Analysis of Pericardial/Pleural Effusions(6 months)
- Absolute and Percent Frequencies of Patients With LDL ≥ 100 mg/mL at 1, 3 and 6 Months, by Treatment Group(6 months)
- Participants With CMV Infection and CMV Syndrome/Disease After 6 Months by Treatment Group(6 months)
- Participants With at Least One Occurrence of Composite Treatment Failure Events(6 months)