Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.

Inclusion criteria

• Male or female with 18 years old or older.
• Transplant patient for at least one year.
• Patient on long-term cyclosporine or tacrolimus.
• Patient whose clinical situation has been stable for at least 3 months, without major treatment modification and without an episode of acute rejection.
• Patient with renal function with a GFR (glomerular filtration rate) greater than or equal to 40 ml/min/1.73m2.
• Patient with systolic blood pressure greater than or equal to 110 mmHg, with or without antihypertensive treatment.
• Patient with the following echocardiographic abnormalities at baseline : an left ventricular mass > to 88 g/m2 in females or > to 102 g/m2 in males and/or left atrial volume > 34 ml/m2.

Exclusion criteria

• Kidney transplant recipient more than 5 years post-transplantation.
• Patient with permanent atrial fibrillation.
• Patient with valvular heart disease (grade ≥ 3).
• Patient considered to be at very high risk of mortality within the next year.
• Patient with documented serum potassium ≥ 5.0 mmol/L within the previous month or receiving long-term potassium-binding resin therapy.
• Patient with documented serum bicarbonate < 20 mmol/L within the previous month, with or without bicarbonate supplementation.
• Patient receiving treatment with a mineralocorticoid receptor antagonist or having a formal indication for such treatment.
• Patient receiving another potassium-sparing diuretic.
• Patient receiving combined treatment with an ACE inhibitor and an angiotensin receptor blocker (each agent being permitted individually).
• Patient receiving digoxin therapy.
• Left ventricular ejection fraction (LVEF) < 40% on the baseline echocardiographic assessment.
• Planned closure of an existing arteriovenous fistula within the following year.
• Known hypersensitivity or allergy to eplerenone or any of its excipients.
• Patient with severe hepatic impairment (Child-Pugh class C).
• Patient currently receiving treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, or nefazodone).
• Patient with known galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption syndrome.
• Patient with a contraindication to Kayexalate®: history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, or concomitant treatment with sorbitol-containing laxatives.
• Woman of childbearing potential not using an effective method of contraception or planning to become pregnant within the next 12 months.
• Patient participating in another interventional clinical study involving modifications to therapeutic management.