Status:
UNKNOWN
Study to Evaluate Effect of Everolimus in Progression of Graft Vascular Illness on Patients With Heart Transplant
Lead Sponsor:
Fundacion Investigacion y Desarrollo
Conditions:
Cardiac Transplant
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 im...
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 medic...
Eligibility Criteria
Inclusion
- Patients suffering a heart transplantation at least 12 months before the inclusion.
- Patients with significant graft vascular cardiac illness.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00695344
Start Date
January 1 2006
End Date
June 1 2010
Last Update
January 30 2009
Active Locations (8)
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1
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain, 08036
2
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08041
3
Hospital de Bellvitge
Barcelona, Barcelona, Spain, 08907
4
Hospital Marqués de Valdecilla
Santander, Cantabria, Spain, 39008