ENHVIE: Everolimus and Tacrolimus Combination for Regression of Left Ventricular Hypertrophy in Renal Transplants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Everolimus arm Patients will be converted from Tacrolimus + Mycophenolate mofetil to Everolimus + Tacrolimus 'Conversion from Mycophenolate mofetil to Everolimus' |
Drug: Everolimus
Conversion from Mycophenolate mofetil to Everolimus
Other Names:
Drug: Tacrolimus
Other Names:
|
Active Comparator: Mycophenolate arm Patients will remain in Tacrolimus + Mycophenolate mofetil combination |
Drug: Mycophenolate mofetil
Patients will remain in Tacrolimus + Mycophenolate mofetil
Other Names:
Drug: Tacrolimus
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Spain | 08907 |
Sponsors and Collaborators
- Edoardo Melilli
Investigators
- Principal Investigator: Edoardo Melilli, MD, Hospital Universitari de Bellvitge
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ENHVIE