Trials · 2025
EVATRAN (The Effect of Eplerenone on the Evolution of Vasculopathy in Renal Transplant Patients): study protocol for a cross-over randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Simon Arnaud, Girerd Nicolas, Jaisser Frédéric, Bozec Erwan, Lepage Xavier, Mercklé Ludovic, Rossignol Patrick, Frimat Luc, Girerd Sophie
Аннотация
BACKGROUND: Arterial stiffness is a major prognostic factor of cardiovascular (CV) morbi-mortality in kidney transplant (KT) patients. Preclinical studies have demonstrated that the vascular toxicity of calcineurin inhibitors (CNI) is mediated through the activation of the mineralocorticoid receptor (MR) in vascular smooth muscle cells. Additionally, the role of MR in contributing to arterial stiffness is well documented in non-transplanted individuals. This study aims to investigate the impact of MR antagonist treatment on the progression of arterial stiffness in KT patients on cyclosporine.
METHODS: This is a randomized, open-label, single-center, cross-over trial involving 36 stable KT patients who have been transplanted for at least 1 year and are maintained on cyclosporine therapy. After a 4-week run-in period, participants will be randomly assigned to one of two groups. Group A will receive eplerenone at a dose of 50 mg daily for 6 months, followed by a 6-month period without treatment. There will be an 8-week washout phase between the treatment and non-treatment periods. Group B will start with 6 months without treatment, followed by the same 8-week washout phase, and then receive eplerenone for 6 months. The primary outcome is to assess the effect of 6 months of eplerenone on arterial stiffness, measured through pulse wave velocity (PWV) using the Sphygmocor® method at the start and end of each treatment period. Secondary outcomes will include changes in (1) central and peripheral blood pressure profiles, (2) intima-media thickness, (3) left ventricular mass, (4) biomarkers of oxidative stress and endothelial dysfunction, and (5) renal graft function markers, such as proteinuria and creatinine levels. Additionally, the incidence of hyperkalemia and episodes of acute renal failure will be monitored.
DISCUSSION: CNI are a key component of immunosuppressive therapy in KT patients. By limiting vascular toxicity through MR blockade, CV risk in these patients may be reduced.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04450953. EudraCT number 2019-004243-74.
METHODS: This is a randomized, open-label, single-center, cross-over trial involving 36 stable KT patients who have been transplanted for at least 1 year and are maintained on cyclosporine therapy. After a 4-week run-in period, participants will be randomly assigned to one of two groups. Group A will receive eplerenone at a dose of 50 mg daily for 6 months, followed by a 6-month period without treatment. There will be an 8-week washout phase between the treatment and non-treatment periods. Group B will start with 6 months without treatment, followed by the same 8-week washout phase, and then receive eplerenone for 6 months. The primary outcome is to assess the effect of 6 months of eplerenone on arterial stiffness, measured through pulse wave velocity (PWV) using the Sphygmocor® method at the start and end of each treatment period. Secondary outcomes will include changes in (1) central and peripheral blood pressure profiles, (2) intima-media thickness, (3) left ventricular mass, (4) biomarkers of oxidative stress and endothelial dysfunction, and (5) renal graft function markers, such as proteinuria and creatinine levels. Additionally, the incidence of hyperkalemia and episodes of acute renal failure will be monitored.
DISCUSSION: CNI are a key component of immunosuppressive therapy in KT patients. By limiting vascular toxicity through MR blockade, CV risk in these patients may be reduced.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04450953. EudraCT number 2019-004243-74.