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Completed

NCT Number: NCT03415750

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

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.

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Key information

Conditions

Hypertrophy, Left Ventricular Cardiomegaly Cardiovascular Diseases Heart Diseases Hypertrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Everolimus

Drug

Conversion from Mycophenolate mofetil to Everolimus

Other names: Certican

Mycophenolate mofetil

Drug

Patients will remain in Tacrolimus + Mycophenolate mofetil

Other names: Cellcept

Tacrolimus

Drug

Other names: Prograf

Primary outcomes

  1. Reduction of Left Ventricular Hypertrophy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Edoardo Melilli

Other

Registry information

Official study 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

Acronym: ENHVIE

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2018
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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