After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials. This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on : * Renal function improvement * Vasculopathy and major cardiac event reduction * Maintenance of immunosuppressive efficacy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
0,75 mg bid, 24 months
Hospices Civils de Lyon
Lyon, France
Evaluation of the renal function, at 12 months after everolimus introduction and doses of anticalcineurins decrease.
Time frame: 12 months
Evaluation of the benefit of everolimus introduction on renal function at 24 months
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of Major Adverse Cardiac Events (MACEs)
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of cardiovascular risk factor (Arterial Tension, diabetes, dyslipidemia, proteinuria)
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of treatment withdrawals
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on incidence of treated acute rejection
Time frame: 24 months
Evaluation of the benefit of everolimus introduction on safety
Time frame: 24 months
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