Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy (NCT00966836) | Clinical Trial Compass
UnknownPhase 3
Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy
Italy100 participantsStarted 2009-04
Plain-language 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 the pathogenesis of CAV, no effective therapy is currently available to treat established CAV and prevent its adverse outcomes. Therefore, the main clinical strategy is based on prevention and treatment of factors known to trigger its development. Although the mechanism is vague, cytomegalovirus (CMV) infection is believed to play a key role in CAV progression.
Two strategies involving administration of specific anti-CMV agents are recommended for prevention of CMV infection/disease: universal prophylaxis and preemptive therapy. The pros and cons of the two strategies are still debated, in the absence of randomized studies addressing graft-related outcomes and viral mechanisms of graft damage, and without any clear evidence of superiority of either approach.
The investigators conceived this randomized prospective project to compare the effect of preemptive anti-CMV strategy with universal anti-CMV prophylaxis on CMV infection and on one-year increase in coronary intimal thickening. Patients will be additionally randomized to receive either mycophenolate mofetil or everolimus, in light of the possible anti-CMV properties of everolimus.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 with MDRD at randomization.
* Written informed consent
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.