Abstract
BackgroundChronic kidney disease (CKD) is common and increasing in prevalence. Cardiovascular disease (CVD) 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.MethodsThe study is a prospective randomised open blinded endpoint (PROBE) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists. 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/1.73 m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25 mg once daily in addition to routine care or routine care alone and followed-up for 36 months.DiscussionBARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of CVD) in patients with stage 3b CKD.Trial registrationEudraCT: 2012-002672-13ISRTN: ISRCTN44522369
Highlights
Chronic kidney disease (CKD) is common and increasing in prevalence
BARACK D is a prospective randomised open blinded endpoint (PROBE) trial to determine the effect of aldosterone receptor antagonists (ARA) on mortality and cardiovascular outcomes in patients with stage 3b CKD
Since spironolactone is well recognised as an effective anti-hypertensive agent for patients with hypertension, even when this is resistant to other drugs [32], the intensive phenotyping of blood pressure, Left ventricular (LV) function, and arterial stiffness in the Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial will enable modelling of the extent to which any positive results may be explained by any BP differences between study arms
Summary
Chronic kidney disease (CKD) is common and increasing in prevalence. Chronic kidney disease (CKD) is increasingly common, affecting around 6% of the UK population [1,2], associated with an age-related decline in renal function that is accelerated in hypertension, diabetes mellitus, obesity, and primary renal disorders [3]. While this high (and rising [4]) prevalence is in part due to the ageing population, it is a result of increases in hypertension and diabetes mellitus. Data from the American National Health and Nutrition Examination Survey determined that in the period 1999 to 2004 the overall prevalence of CKD stages 1 to 4 increased significantly when compared to the survey period 1988 to 1994 (13.1% versus 10.0%) [4,9,10]
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