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A multi-centre, prospective, randomized, open, blinded end-point, 36-month study of 2616 patients within primary care with Stage 3b Chronic Kidney Disease to compare the efficacy of spironolactone 25mg once daily in addition to routine care on mortality and cardiovascular outcomes verses routine care alone Background CKD is common and increasing in prevalence. Cardiovascular disease is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway. Methods The study is a Prospective Randomised Open Blinded Endpoint-PROBE trial. The study is set in primary care where patients will primarily be identified by their GPs. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30-44 ml/min/1.73m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25mg OD in addition to routine care or routine care alone. Patients will be followed up for 36 months Discussion BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of cardiovascular disease) in patients with stage 3b CKD.

More information

Publication Date

08/05/2014

Volume

15:160

Addresses

Nathan.Hill@phc.ox.ac.uk

Keywords

Chronic Kidney Disease Cardiovascular, CKD CVD, CKD mortality, CKD aldosterone receptor antagonist, ARA CVD