SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
SCHEDULE - Scandinavian Heart Transplant Everolimus de Novo Study With Early Calcineurin Inhibitor (CNI) Avoidance
A controlled, randomized, open-label, multicenter study evaluating if early initiation of
 everolimus and early elimination of cyclosporine in de novo heart transplant recipients can
 improve long-term renal function and slow down the progression of chronic allograft
 vasculopathy
This was a prospective, multi-center, randomized, controlled, parallel group, open label
 study in de novo heart transplant recipients. Patients eligibility for randomization was
 assessed 5 days after heart transplant.. Patients fulfilling the inclusion and exclusion
 criteria were randomized to one of two treatment groups: either conventional treatment with
 Cyclosporine A (CsA), Mycophenolate mofetil (MMF), and corticosteroids (Group A), or low-dose
 CsA and everolimus, reduced dose MMF, and corticosteroids (Group B). After 7 to 11 weeks, CsA
 was discontinued in Group B, while the standard triple-drug immunosuppressive regimen was
 maintained in Group A.
De novo heart transplant recipients who had received induction therapy with antithomocyte
 globulin (ATG) were eligible for inclusion.

 Recipients of multi-organ transplants or a previous transplant were excluded, as were those
 with a donor aged > 70 years, cold ischemia time >6 hours, patients with severe systemic
 infection, recipients of ABO incompatible transplants, patients with severe
 hypercholesterolemia (>350mg/dL) or hypertriglyceridemia (>750 mg/dL), patients with past
 (<5 years). In order to continue in the study after week 7-11 (period 1), patients had to
 complete first 7-11 weeks on randomized immunosuppression and none of the following
 criteria should be present: Ongoing rejection treatment or experience of one grade 3R
 rejection or two or more grade 2R rejections during first 7-11 weeks.