Effect of Everolimus on Left Ventricular Hypertrophy of de novo Kidney Transplant Recipients: a 1 Year, Randomized, Controlled Trial.
Paoletti E, Marsano L, et al.Transplantation, 93(5): 503-508, 2012.
Aims
To evaluate the impact of an immunosuppressive regimen consisting of everolimus plus reduced exposure cyclosporine A (CsA) on the left ventricular mass index (LVMi) in non-diabetic renal transplant patients.
Interventions
Everolimus plus reduced-exposure CsA versus standard dose CsA. All patients were given anti-IL-2 receptor monoclonal antibodies induction therapy and steroids.
Participants
30 non-diabetic patients who received a single kidney graft from a deceased donor.
Outcomes
Main outcome was LVMi calculated by the end systolic and diastolic diameters of left ventricular, end-diastolic interventricular septum thickness and end-diastolic left ventricular posterior wall thickness. Other outcomes included blood pressure, serum creatinine, hemoglobin, uric acid, lipids, time of discharge from the transplant unit after hospitalization for grafting and urinary protein excretion rate.
Follow-up
12 months
CET Conclusions
In this small but well designed trial patients receiving de novo everolimus plus reduced CsA showed a regression in left ventricular hypertrophy, regardless of blood pressure, compared to patients on standard dose cyclosporine. This was due mainly to a reduction in the thickness of the left ventricular wall.
Data analysis
Modified intention-to-treat analysis
Trial registration
ISRCTN93681079 (ISRCTN)