ALdosterone Antagonist Chronic HEModialysis Interventional Survival Trial (ALCHEMIST)

This is an interventional treatment trial for End Stage Renal Failure on Dialysis focused on measuring chronic kidney disease, end-stage renal disease, hemodialysis (ESRD), cardiovascular morbimortality, aldosterone antagonist, spironolactone Read More

Inclusion Criteria:

• Written informed consent.
• Adult men and women on HD for at least 45 days for ESRD regardless of the etiology including diabetes, with at least 3 HD sessions per week
• Presenting at least one of the follow comorbidities, cardiovascular abnormalities or CV risk factors:
• Left ventricular hypertrophy defined by left ventricular mass > 130 g/m2 in men and 100 g/m2 in women (echocardiography)
• OR Cornell (RaVL + SV3) >28 mm in men, > 20 mm in women(ECG)
• OR left ventricular ejection fraction < 40%
• OR large QRS > 0.14 sec
• OR Left bundle branch block (ECG) measured during the twelve months preceding inclusion; diabetes;
• OR history of cardiovascular disease: coronary artery disease, symptomatic lower limb peripheral arterial disease, carotid or renal artery stenosis > 50%, stroke, hospitalization for heart failure, permanent atrial fibrillation (AF), oral anticoagulant treatment for AF, valvular heart prosthesis,
• OR CRP > 5 mg/l for 3 months without infectious or neoplastic disease documented in progress

Exclusion Criteria:

• history of hypersensitivity to spironolactone or galactose intolerance
• the Lapp lactase deficiency or malabsorption of glucose or galactose
• hyperkalemia > 5.5 mmol/l during the two weeks prior to enrolment
• history of unscheduled hemodialysis for hyperkalemia during the last six months
• hospitalization for hyperkalemia during the last six months
• patients with imperative indication of a combination of ACEI and sartan or renin inhibitor (each being authorized separately), NSAIDS, Cox-2 inhibitors
• kidney transplant scheduled within the year
• symptomatic interdialytic hypotension
• acute systemic disease
• uncompensated hypothyroidism
• acute hyperthyroidism
• any prior or concomitant clinical condition compromising the inclusion, in the discretion of the investigator
• cardiac transplant
• severe uncontrolled arrhythmia
• stroke within 3 months prior to enrolment
• acute coronary syndrome in the previous month inclusion
• recent (1 month) or planned coronary revascularization by angioplasty
• recent (3 months) or planned cardiovascular surgery (excluding HD vascular access)
• non menopausal women or without effective contraceptive methods
• pregnancy, breastfeeding or planning a pregnancy within 2 years
• non compliance
• protected adult
• SBP > 200 mmHg and/or DBP > 110 mmHg
• Concomitant treatment can not be stopped by another potassium-sparing diuretic, a potassium supplements, AINS or Cox 2 inhibitors