Scandinavian Heart Transplant de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance (SCHEDULE)

Inclusion Criteria:

1. Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
2. Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months
3. Patients received induction therapy with ATG (Thymoglobulin)

Exclusion Criteria:

1. Recipient of multi-organ transplants or previously transplanted organs
2. Patients with donor greater than 70 years
3. Donor heart cold ischemic time > 6 hours.
4. Patients who are recipients of ABO incompatible transplants
5. Patients with platelet count < 50,000/mm3 at the evaluation before transplantation
6. Patient who have received an unlicensed drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation
7. Patient with a known hypersensitivity to cyclosporine
8. Patient with a current severe systemic infection
9. Patient unable to participate in the study for the full 12-month period
10. Presence of severe hypercholesterolemia (≥ 350 mg/dL; ≥ 9 mmol/L) or hypertriglyceridemia (≥ 750 mg/dL; ≥ 8.5 mmol/L)
11. Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
12. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
13. Patients with HIV, hepatitis B or C.