Hypertrophy, Left Ventricular
Conditions
Keywords
Renal transplant
Brief summary
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.
Detailed description
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.
Interventions
DRUGEverolimus
Conversion from Mycophenolate mofetil to Everolimus
DRUGMycophenolate mofetil
Patients will remain in Tacrolimus + Mycophenolate mofetil
DRUGTacrolimus
Sponsors
Edoardo Melilli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Left Ventricular Hypertrophy | 12 months | Reduction of Left Ventricular Hypertrophy more or equal than 10 g/m2 in the study group compared to control group at 12 months. Regression of LVH is defined as a decrease of 10 g/m2 compared to baseline value. Cardio nuclear magnetic resonance will be performed to evaluate left ventricular hypertrophy |
Countries
Spain
Outcome results
None listed