Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.