Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant (EVEROSTAT)
Recruitment status was Active, not recruiting
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.
Drug: azathioprine or mycophenolate mofetil
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective and Randomized Study to Evaluate the Effect of Everolimus in the Clinical and Intra-Cardiac Ecography Progression of Heart Graft Vascular Illness.|
- 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. [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
- Intra-coronary ultrasound, safety and adverse events, Nt-proBNP, left ventricular systolic function, coronary stenosis. [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2006|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Everolimus 2 times per day + cyclosporin low dose +/- steroids
Everolimus 2 times per day, v.o., 2 years treatment.
Other Name: Certican
Active Comparator: 2
Cyclosporin + azathioprine or mofetil mycophenolate +/- steroids (the same treatment that patient had before the study).
Drug: azathioprine or mycophenolate mofetil
2 times per day during 2 years
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695344
|Hospital Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Clínica Universitaria de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Hospital Clinic de Barcelona|
|Barcelona, Spain, 08036|
|Hospital de Bellvitge|
|Barcelona, Spain, 08907|
|Hospital Santa Creu i Sant Pau|
|Barcelona, Spain, 08041|
|Hospital 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Gregorio Marañón|
|Madrid, Spain, 28007|
|Hospital Puerta de Hierro|
|Madrid, Spain, 28035|
|Principal Investigator:||Javier Segovia, cardiologist||Hospital Puerta de Hierro|
|Principal Investigator:||Nicolás Manito, Cardiologist||Hospital Universitari de Bellvitge|
|Principal Investigator:||Gregorio Rábago, Cardiologist||Clínica Universitaria de Navarra|
|Principal Investigator:||Francisco González-Vílchez, Cardiologist||Hospital Marqués de Valdecilla|
|Principal Investigator:||Juan Delgado, Cardiologist||Hospital 12 de Octubre|
|Principal Investigator:||Juan Fernández Yañez, Cardiologist||Hospital Gregorio Marañón|
|Principal Investigator:||Sonia Mirabet, Cardiologist||Hospital Santa Creu i Sant Pau|
|Principal Investigator:||Eulalia Roig, Cardiologist||Hospital Clinic de Barcelona|