Impact of early conversion from cyclosporin to everolimus on left ventricular mass index: a randomized controlled trial

This is an 18-month prospective, randomized controlled trial (RCT) designed to compare the effect of early conversion from cyclosporin to everolimus/ mycophenolic acid (E-MPA) between 3-4 months post-transplant to cyclosporin/mycophenolic acid (CsA-MPA) on left ventricular mass index (LVMI) at 3 and 18 months post-transplant (primary outcome). Secondary outcomes included estimated glomerular filtration rate (eGFR), viral infection and adverse events. Twenty-four patients were randomized in a 1:1 ratio to E-MPA or CsA-MPA groups. There were no significant differences in mean (SD) LVMI at 3 (51.6±18.5 vs. 53.7±15.7g/m2.7 ) and 18 months (52.7±16.3 vs. 51.7±16.8g/m2.7 ) between CsA-MPA and E-MPA groups. The incidence of viral infections was reduced in E-MPA compared to CsA-MPA treatment groups (8% vs. 50%, p=0.02), but the incidences of acute rejection, adverse events and drug discontinuation were similar between groups. There was an overall increase in eGFR with time (0.04 log- ml/min/1.73m2 per 6 months, p=0.012) but no significant difference between the two groups across time (0.11 log- ml/min/1.73m2 , p=0.311). Immunosuppressive regimen comprising of early conversion from cyclosporine to everolimus was not associated with a regression of LVMI, but a lower risk of viral infections was observed. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12610000320055).