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Prevention of Transplant Atherosclerosis With Everolimus and Anti-cytomegalovirus Therapy

2014-08-27 03:19:44 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Heart Transplantation

Intervention

Pre-emptive strategy with valganciclovir plus everolimus, Prophylaxis with valganciclovir plus mycophenolate, Prophylaxis with valganciclovir plus everolimus, Pre-emptive mycophenolate

Location

Azienda Ospedaliero-Universitaria S Orsola Malpighi
Bologna
Italy

Status

Recruiting

Source

University of Bologna

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:44-0400

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Medical and Biotech [MESH] Definitions

An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.

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Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.

An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza.

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