Everolimus in de Novo Heart Transplant Recipients

Early vs. Delayed EVERolimus in de Novo HEART Transplant Recipients: Optimization of the Safety/Efficacy Profile (EVERHEART Study)

The purpose of this study, in de novo heart transplant patients, is to evaluate whether delayed introduction of everolimus reduces the occurrence of wound healing problems, pericardial and/or pleural effusion and early acute renal insufficiency, as compared with immediate introduction of everolimus, in the firs six months after heart transplantation.

Inclusion criteria:

• Male or female cardiac transplant candidates 18-65 years of age undergoing primary heart transplantation.
• Glomerular filtration rate (GFR by MDRD) ≥ 40 mL/min/1.73 m2 at randomization

Exclusion criteria:

• Patients who are recipients of multiple solid organ transplants
• Patients who are HIV-positive or Hepatitis C positive (PCR only) or B-surface antigen positive;
• Presence of Donor/Recipients serological mismatch for Hepatitis B or C;
• Recipients of organ from donors positive for Hepatitis B-surface antigen;
• Panel Reactive Antibodies (cytotoxicity method) > 30%.
• Other protocol-defined inclusion/exclusion criteria may apply