1. RAD Immunosuppression in Heart Transplant Recipients Duke Heart Failure Research Pager: 970-0736

2. Purpose Evaluate efficacy and safety comparing two concentrations of Certican with reduced Neoral dose vs. MMF* with standard Neoral dose in de novo heart transplant recipients This is a study of immunosuppressant drugs *Mycophenolate mofetil (Cellcept) = MMF

3. Inclusion Criteria Male or female cardiac recipients 18-70 years old undergoing heart transplantation. Graft is functional at time of randomization. Females must have negative pregnancy test prior to randomization and use of effective contraception during the treatment and 3 months after medications are discontinued. This study is not currently enrolling.

4. Interventions Investigational drug: Everolimus (Certican) Everolimus (Certican) Control drug: Mycophenolate mofetil (Cellcept) Mycophenolate mofetil (Cellcept) Both drugs in combination with Cyclosporine (Neoral) and corticosteroids. There is not a placebo in this study. These drugs are supplied by the investigational pharmacy except for the corticosteroids. Investigational pharmacy # 684-3543.

5. Interventions Randomized to 1 of 3 groups 72 hours after transplantation Certican 0.75 mg BID, Neoral (reduced dose), steroids Certican 1.5 mg BID, Neoral (reduced dose), steroids MMF 1500 mg BID, Neoral (standard dose), steroids

6. In Certican groups, therapeutic drug levels will be monitored throughout the study. Treatment lasts 24 months. No follow-up. Serious adverse effects are recorded for 4 weeks after the treatment ends.

7. Nursing Roles If an enrolled subject is admitted to the hospital, please notify the research study team (970-0736) to obtain study medications. The admitting MD may enter a CPOE order stating patient may take home study meds x24 hrs until the study drugs can be obtained from the investigational pharmacy.

8. Outcomes Why is this study being done? To compare the investigational drug Everolimus (Certican) with control drug Mycophenolate mofetil (Cellcept) to determine: Efficacy failure rates (evidence of acute rejection by biopsy) Rates of graft loss or re-transplant, death, or loss to follow-up Renal function (GFR)