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

Hypertrophy, Left Ventricular Clinical Trial

— ENHVIE  

Official title:

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT03415750
• Other study ID #: ENHVIE
• Status: Completed
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: May 2020

Study information

• Verified date: January 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertrophy
• Hypertrophy, Left Ventricular

Intervention

Drug:
• Everolimus
Conversion from Mycophenolate mofetil to Everolimus
• Mycophenolate mofetil
Patients will remain in Tacrolimus + Mycophenolate mofetil
• Tacrolimus

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Edoardo Melilli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of Left Ventricular Hypertrophy	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	12 months