Prospective and Randomized Study to Evaluate the Effect of Everolimus in the Clinical and Intra-Cardiac Ecography Progression of Heart Graft Vascular Illness.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 52
- 试验地点
- 8
- 主要终点
- Percentage of subjects that present at least one major clinical event due to graft vascular illness during the first year of the study on both treatment arms.
研究概览
简要总结
The purpose of this study is to evaluate if there is a significantly less incidence of major clinical events due to graft vascular illness in recipients of a cardiac transplant on treatment with an immunosuppressive combination, which includes Everolimus, compared to those that continue the previously used immunosuppressive treatment.
详细描述
This is a prospective, randomized, multicentre, open and controlled study, to evaluate the efficacy and safety of everolimus combined with cyclosporin for microemulsion and steroids according to medical judgement, opposite to the usual therapy which the patient already has received (typically: ciclosporin + azathioprine or mycophenolate mofetil + steroids according to the judgement of the doctor) for patients receiving a cardiac orthotopic transplant since at least 12 months. The patients will be randomized in a 2:1 proportion (everolimus:control), in order to make it possible for the majority of patients to receive the potentially active treatment in a lethal illness for which there is not efficient known treatment up to date.
The study duration will be 2 years of follow-up for each patient. At the end of this period, the patients will be offered the possibility to maintain the immunosuppressive treatment to which they have been assigned, and periodic revisions will be made each 3-6 months.
The two treatment groups are:
Group I - Everolimus twice a day v.o. + cyclosporin for microemulsion in reduced doses +/- steroids.
Group II - Cyclosporin for microemulsion + azathioprine or mycophenolate mofetil +/- steroids (the same administration schedule and medication which the patient received earlier).
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
- •Patients suffering a heart transplantation at least 12 months before the inclusion.
- •Patients with significant graft vascular cardiac illness.
排除标准
- •Patients who received more than one solid organ.
- •Hypersensibility to everolimus.
- •Patients with expected surviving less than 6 months.
- •Analytic abnormality significant (platelets < 70.000 plat./mm3, WBC<4.000./mm3, creatinine > 2,5 mg/dl)
- •Neoplasm and/or severe systemic illness.
- •Mental significant illness.
- •Patients who have received sirolimus or everolimus in any moment after transplant.
- •Pregnant or lactating woman.
研究组 & 干预措施
1
Everolimus 2 times per day + cyclosporin low dose +/- steroids
干预措施: everolimus (Drug)
2
Cyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study).
干预措施: azathioprine or mycophenolate mofetil (Drug)
结局指标
主要结局
Percentage of subjects that present at least one major clinical event due to graft vascular illness during the first year of the study on both treatment arms.
时间窗: December 2010
次要结局
- Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis.(December 2010)