Efficacy and safety of anti-cytomegalovirus prophylaxis versus pre-emptive approaches with valganciclovir in heart transplant recipients treated with everolimus or mycophenolate. A randomized open-label study for prevention of cardiac allograft vasculopathy - PROTECT
- Conditions
- Heart transplantationMedDRA version: 9.1Level: LLTClassification code 10019315Term: Heart transplant rejection
- Registration Number
- EUCTR2008-006980-35-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Age ≥ 18y - Heart or heart-kidney combined transplant - Positive CMV serology at the time of transplant - Glomerular filtration rate ≥ 20 ml/min/1.73m2 estimated with MDRD formula at the time of randomization. - Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 hemodyalisis treatment - Intolerance towards valganciclovir, everolimus, mycophenolate or cyclosporine - 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 informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method