Heart transplantation MedDRA version: 9.1 Level: LLT Classification code 10019315 Term: Heart transplant rejection
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Valganciclovir
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 450-
Trade Name: CERTICAN
Pharmaceutical Form: Tabl
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - Panel Reactive Antibody &#8805;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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare development of CAV detected by intravascular ultrasound (IVUS) in heart recipients randomized either to a pre-emptive anti-CMV strategy or universal anti-CMV prophylaxis based on valganciclovir administration. CAV will be defined by the change in maximal intimal thickness between baseline and year-1 IVUS, which is the major surrogate measure for long-term survival after heart transplantation;Secondary Objective: To investigate the interplay of the treatment with everolimus (EVE) or mycophenolate mofetil (MMF) with either of CMV preventive strategy in influencing CMV infection and CAV development. Exploratory objectives a) Host cell-mediated response against the virus b) Evaluation of coronary-flow reserve c) Evaluation of time course of cellular and humoral acute rejection b) Pharmacoeconomic evaluation in terms of cost for drugs, required assays for CMV detection, side effects, and hospitalizations;Primary end point(s): Change in maximal intimal thickness between baseline and follow-up IVUS is the main outcome measure. | — |
Countries
Italy
Outcome results
None listed