Conditions: Cardiac Allograft Vasculopathy Heart Transplant Recipients
Keywords: cardiac allograft vasculopathy (CAV) prevention cardiac transplantation rituximab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 362
Healthy volunteers: no

Brief summary:
All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function. People who develop antibodies after transplant have a higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the risk of developing CAV. People who develop CAV usually have to receive another transplant.

Detailed description:
The purpose of this research study is to see if a study drug called rituximab (Rituxan®) prevents CAV. Rituximab destroys certain types of white blood cells called B cells. B cells are important cells in the immune system that help the body fight infection by producing substances called antibodies. B cells and the antibodies they produce are also involved in some kinds of rejection after organ transplantation. Rituximab decreases the number of B cells in the blood and other tissues. The goal of this study is to determine if decreasing B cells with Rituximab can prevent injury to the transplanted heart.

Arms:
arm 1: Rituximab induction/conventional immunosuppression arm 2: Rituximab Placebo / conventional immunosuppression

Interventions: intervention 1: Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper) intervention 2: Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: