| Participants |
Estimated enrolment: 825
Inclusion criteria
Written informed consent Adult men and women on HD for at least 45 days for ESKD regardless of the aetiology including diabetes, with at least 3 HD sessions/week Presenting at least one of the follow co‐morbidities, cardiovascular abnormalities, or CV risk factors: -
LVH defined by
LVM > 130 g/m² in men and 100 g/m² in women (ECG), OR Cornell (RaVL + SV3) >28 mm in men, > 20 mm in women (ECG), OR Left ventricular EF < 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, hospitalisation for heart failure, permanent 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 Lapp lactase deficiency or malabsorption of glucose or galactose Hyperkalaemia > 5.5 mmol/L during the 2 weeks prior to enrolment History of unscheduled HD for hyperkalaemia during the last 6 months Hospitalisations for hyperkalaemia during the last 6 months Patients with imperative indication of a combination of ACEi and ARB or renin inhibitor (each being authorised 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 CV 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 mm Hg and/or DBP > 110 mm Hg Concomitant treatment cannot be stopped by another potassium‐sparing diuretic, a potassium supplements, NSAID or Cox 2 inhibitors
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| Outcomes |
Primary outcome
Secondary outcome
The cumulate rate of non‐fatal MI or acute coronary syndrome, hospitalisation for heart failure, non‐fatal stroke, or CV death [Time Frame: 25 months] The time to onset of death from i) any cause and ii) from a CV event and iii) from a non CV cause [Time Frame: 25 months] The time of survival without a major CV event (non fatal MI, acute coronary syndrome, hospitalisation for heart failure, non‐fatal stroke, cardiac arrest resuscitation) [Time Frame: 25 months] Incidence of procedures related to stenosis or vascular access thrombosis for HD [Time Frame: 25 months] Incidence of coronary or peripheral revascularizations (including lower limb amputations) [Time Frame: 25 months] BP and its inter‐visit variability [Time Frame: 25 months] The occurrence of atrial fibrillation [Time Frame: 25 months] Incidence of hyperkalaemia > 6 mmol/L [Time Frame: 25 months] Estimation of the effect of treatment on quality of life. [Time Frame: 25 months]
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