Status:
UNKNOWN
Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy
Lead Sponsor:
University of Bologna
Conditions:
Heart Transplantation
Cardiac Allograft Vasculopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Cardiac allograft vasculopathy (CAV) is the major cause of long-term graft failure in heart transplant recipients. Although several immune-mediated and metabolic risk factors have been implicated in t...
Eligibility Criteria
Inclusion
- Age ≥ 18y
- Heart or heart-kidney combined transplant
- Positive CMV serology at the time of transplant
- Glomerular filtration rate ≥ 20 ml/min/1.73m2 with MDRD at randomization.
- Written informed consent
Exclusion
- Panel Reactive Antibody ≥50%
- Less than 1000/mmc neutrophils at the time of randomization
- Less than 30,000/mmc platelets at the time of randomization
- Clinical significant infection in the 2 weeks prior to transplant
- Glomerular filtration rate \< 20 ml/min/1.73m2 estimated with MDRD formula at the time of randomization or hemodialysis treatment
- Intolerance towards valganciclovir, everolimus, mycophenolate or cyc-losporine
- Known contraindication to statin use
- Negative CMV serology at the time of transplant
- HIV positive testing
- Severe comorbidities that, based on investigator's judgment, contraindicate study drugs or procedures
- Potentially childbearing women who refuse to use contraceptives
- Participation to an interventional study in the 2 preceding weeks
- Unwillingness or inability to follow study procedure and to sign written in-formed consent
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00966836
Start Date
April 1 2009
Last Update
August 27 2009
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria S Orsola Malpighi
Bologna, Italy