Background: Left ventricular hypertrophy (LVH) is common in kidney transplant recipients (KTxR) and has shown to be a risk factor for death and heart failure after KTx. An early switch from a CNI to everolimus (EVR)-based regimen may prevent the post-KTx CVD risk. ELEVATE study (NCT01114529) evaluated the effect of EVR on LVH in de novo KTxR vs standard CNI. Methods: In this 24-month (M), multicenter, open-label study, de novo KTxR were randomized (RND) after 10-14 weeks to EVR (C0 6–10ng/mL) or continued standard CNI (C0, tacrolimus: 5–10ng/mL, cyclosporine: 100–250ng/mL). All patients received enteric-coated mycophenolate sodium and steroids. Left ventricular mass (LVM) was assessed at RND and M12 using echocardiography (ECG). LVM index (LVMi) was calculated using LVM and indexed by height^2.7. LVH was considered if LVMi >49.2g/m^2.7 for male and >46.7g/m^2.7 for female. In addition, sensitivity analysis utilizing BSA indexation was performed. Patients with data for ECG variables at both RND and M12 visits were included in the analyses. Results: Overall, 527 patients (EVR, 245 and CNI, 282) were included in the analysis. LVH at RND was detected in 133 EVR (36.8% concentric, 63.2% eccentric) and 151 CNI patients (44.4% concentric, 55.6% eccentric). LVH at M12 was observed in 126 EVR (38.1% concentric, 61.9% eccentric) and 137 CNI patients (48.9% concentric, 51.1% eccentric). At M12, LS mean difference for LVMi in LVH patients was -5.74g/m^2.7 and -4.25g/m^2.7 for EVR vs CNI respectively with a difference not statistically significant (LS Mean 5.94g/m^2.7 [95%CI -1.35, 13.23]; p=0.11). Additionally, change in LVMi for concentric LVH was -5.71g/m^2.7 and -4.25g/m^2.7 (mean difference: -1.49g/m^2.7; p=0.58) for EVR and CNI, respectively. The change in LVMi for eccentric LVH was 5.10g/m^2.7 and -4.48g/m^2.7 (mean difference: 9.58 g/m^2.7, p=0.10) for EVR and CNI, respectively. Fewer patients in EVR vs CNI arm had increased concentric LVH (+1.3% vs +4.5%) and a reduction in eccentric LVH (-1.3% vs -4.5%). Sensitivity analysis performed by utilizing BSA indexation provided similar results. Conclusion: After only 9M post-CNI conversion, 12M analysis showed a differential effect of the two treatments on LVMi, being more favorable for EVR on patients with concentric LVH and for CNI on patients with eccentric LVH.

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