Transplant Trial Watch

The impact of mTOR inhibitors in the regression of left ventricular hypertrophy in elderly kidney transplant recipients.

David-Neto, E., et al.

Clinical Transplantation 2022 [record in progress].

This substudy of the nEverOld trial aimed to analyse the impact of two different immunosuppressive regimens (tacrolimus (TAC)/everolimus (EVL) versus tacrolimus/mycophenolate sodium (MPS)) on the regression of left ventricular hypertrophy (LVH) in elderly kidney transplant recipients.

Participants in the nEverOld trial were randomised to either the EVL/TAC group or the MPS/TAC group.

110 elderly kidney transplant recipients.

The main outcomes of interest were regression of LVH and septum hypertrophy.

4 years

CET Conclusions
This analysis of a secondary outcome from the nEverOld study investigates the impact of a switch to everolimus-based immunosuppression in elderly renal transplant recipients on left ventricular mass. The authors randomised 100 recipients to everolimus and low-dose tacrolimus, or MPS and regular dose tacrolimus. No significant differences were observed in left ventricular mass or septal thickness between groups. Whilst patients and clinicians were not blinded to the intervention group, physicians undertaking the echocardiograms were (although it is not described how this was maintained). Intent-to-treat analysis is performed, and there was some crossover between groups during the study (10 patients in the MPS group started everolimus, and 4 patients taking everolimus stopped). It should be noted as this was a secondary endpoint in the study, the trial is most likely not powered to demonstrate small differences in cardiac parameters. Nevertheless, the results presented do not show any suggestion of a clinically meaningful effect.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Trial registration - NCT01631058

Funding source
Industry funded