Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy (PROTECT)
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|ClinicalTrials.gov Identifier: NCT00966836|
Recruitment Status : Unknown
Verified August 2009 by University of Bologna.
Recruitment status was: Recruiting
First Posted : August 27, 2009
Last Update Posted : August 27, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Transplantation Cardiac Allograft Vasculopathy Cytomegalovirus Infection||Drug: Pre-emptive strategy with valganciclovir plus everolimus Drug: Prophylaxis with valganciclovir plus mycophenolate Drug: Prophylaxis with valganciclovir plus everolimus Drug: Pre-emptive mycophenolate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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 Cardiaca Allograft Vasculopathy|
|Study Start Date :||April 2009|
|Estimated Primary Completion Date :||April 2012|
|Experimental: Pre-emptive everolimus||
Drug: Pre-emptive strategy with valganciclovir plus everolimus
Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Everolimus plus cyclosporine and prednisone will be used for maintenance immunosuppression
|Experimental: Prophylaxis mycophenolate||
Drug: Prophylaxis with valganciclovir plus mycophenolate
Patients will receive 3 months of oral valganciclovir with mycophenolate and standard cyclosporine and prednisone for maintenance immunosuppression
|Experimental: Prophylaxis Everolimus||
Drug: Prophylaxis with valganciclovir plus everolimus
Patients will receive valganciclovir for 3 months after transplant. Everolimus plus reduced cyclosporine and prednisone will be used for maintenance immunosuppression
|Active Comparator: Pre-emptive mycophenolate||
Drug: Pre-emptive mycophenolate
Patients will be monitored for CMV infection and receive valganciclovir only for positive PCR or antigenemia. Mycophenolate plus standard cyclosporine and prednisone will be used for maintenance immunosuppression
- Change in maximal intimal thickness [ Time Frame: one year ]
- CMV infection [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966836
|Contact: Luciano Potena, MD PhDfirstname.lastname@example.org|
|Contact: Francesco Grigioni, MD PhDemail@example.com|
|Azienda Ospedaliero-Universitaria S Orsola Malpighi||Recruiting|
|Sub-Investigator: Luciano Potena, MD PhD|