Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant
NCT00695344 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2009-01-30
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.
Conditions
- Cardiac Transplant
Interventions
- DRUG
-
Everolimus 2 times per day, v.o., 2 years treatment.
- DRUG
-
azathioprine or mycophenolate mofetil
2 times per day during 2 years
Sponsors & Collaborators
-
Fundacion Investigacion y Desarrollo
lead OTHER
Principal Investigators
-
Javier Segovia, cardiologist · Hospital Puerta de Hierro
-
Nicolás Manito, Cardiologist · Hospital Universitari de Bellvitge
-
Gregorio Rábago, Cardiologist · Clínica Universitaria de Navarra
-
Francisco González-Vílchez, Cardiologist · Hospital Marqués de Valdecilla
-
Juan Delgado, Cardiologist · Hospital 12 de Octubre
-
Juan Fernández Yañez, Cardiologist · Gregorio Marañón Hospital
-
Sonia Mirabet, Cardiologist · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
-
Eulalia Roig, Cardiologist · Hospital Clinic of Barcelona
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-01-31
- Primary Completion
- 2010-06-30
- Completion
- 2010-06-30
Countries
- Spain
Study Locations
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