Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up

Inclusion Criteria: * Age ≥ 18 year * Signed informed consent * 6 months to 15 year after heart transplantation * Stable heart allograft function without rejection for at least 12 months * Same immunusuppressive drugs for at least 3 months * CNI based immunusuppression, with Cyclosporin levels C0 100-200 ng/ml FK levels of 5-10 ng/ml for preserved CNI levels. * Poor renal function: creatinine \> 1.5 mg%. Exclusion Criteria: * Suspected non-compliance * Intolerance to Everolimus * Life expectancy \< 1year * Proteinuria \> 1.5 g/24u/1.73m2 * Previous sirolimus treatment * Patients who received any other investigational drug * Patients with platelet count \<50,000/mm³ before baseline. * Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L) * Patients with an absolute neutrophil count of ≤ 1,500/mm3 or white blood cell count of ≤ 4000/mm³ at baseline * Patients with a known hypersensitivity to similar drugs and to the components of the formulations * Patients being treated with terfenadine, astemizole, or cisapride. * Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4. * Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma) * Patients with clinically significant systemic infection. * Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer. * Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.