Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants

A Single-center,Randomized,Open-label,12 Months Study,2 Parallel Group to Compare the Efficacy of Everolimus Combination + Tacrolimus in Regression of Left Ventricular Hypertrophy vs Tacrolimus + MMF in Renal Transplant Patients

Clinical study with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tacrolimus + mycophenolate mofetil in renal transplant patients in the maintenance phase.

Inclusion Criteria:

• Patient's signed informed consent prior to any study-related procedure.
• Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
• Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
• Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
• Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
• No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
• Patients with Hb levels ≥ 11 gr/dl.
• Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.

Exclusion Criteria:

• Patient's signed informed consent prior to any study-related procedure.
• Adult patients (> 18 years), renal transplant recipients of more than 1 year of evolution.
• Patients receiving maintenance immunosuppression with tacrolimus delayed release (Envarsus®) and MMF / MPA.
• Patients with Left Ventricular Hypertrophy detected by Cardio-NMR.
• Subjects with glomerular filtration rate >30 ml/min (calculated by CKD-EPI) and stable in the last two analytical determinations (variation <20%).
• No known contraindications to the use of Mtor inhibitors (previous intolerance, deep vein thrombosis , pulmonary embolism, proteinuria > 0.5 g/day)
• Patients with Hb levels ≥ 11 gr/dl.
• Patients with blood pressure <140/90 mmHg in the hospital visits or <135/85 mmHg at home.