Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant
- Conditions
- Cardiac Transplant
- Interventions
- Registration Number
- NCT00695344
- Lead Sponsor
- Fundacion Investigacion y Desarrollo
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
- Patients suffering a heart transplantation at least 12 months before the inclusion.
- Patients with significant graft vascular cardiac illness.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 azathioprine or mycophenolate mofetil Cyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study). 1 everolimus Everolimus 2 times per day + cyclosporin low dose +/- steroids
- Primary Outcome Measures
Name Time Method 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. December 2010
- Secondary Outcome Measures
Name Time Method Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis. December 2010
Trial Locations
- Locations (8)
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital Puerta de Hierro
🇪🇸Madrid, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain