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Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.
Sponsor: Central Hospital, Nancy, France
Summary
The main objective of this research is to evaluate the effect, for 36 weeks, of eplerenone on abnormalities observed on cardiac ultrasound in patients with kidney transplantation for at least one year, under cyclosporine or tacrolimus. The intervention group will receive the usual standard treatment coupled with eplerenone for 36 weeks from randomization, while the control group will only receive the standard treatment. The main hypothesis is that anticalcineurins (cyclosporin or tacrolimus) lead to activation of the MR of vascular smooth muscle cells, vasoconstriction and vascular inflammation, which contributes to the persistence or recurrence of heart abnormalities in these patients after the initial post-transplant phase. The administration of eplerenone could antagonize this hyperactivation, reduce the cardiovascular effects of anticalcineurins and thus ultimately improve the cardiovascular prognosis of transplant patients.
Official title: Randomized Controlled Trial Evaluating the Impact of Mineralocorticoid Receptor Blockade by Eplerenone on Echocardiographic Abnormalities Among Kidney Graft Recipient Under Calcineurin Inhibitors. KT-CANOPY: Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2027-02
Completion Date
2030-12
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
Eplerenone
The intervention group will receive standard treatment according to usual care, coupled with eplerenone for 36 weeks from randomization. Start of treatment with eplerenone at the initial dose of 25 mg/day, then adjusted according to clinical and biological tolerance: 12.5 mg/day (i.e., 25 mg/48h), 25 mg/day, and 50 mg/day.
Locations (3)
CHU Nantes
Nantes, France
CHU Strasbourg - nouvel hôpital Civil
Strasbourg, France
CHRU Nancy - hôpital Brabois
Vandœuvre-lès-Nancy, France