Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial-a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial
Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial-a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial
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DOI：
10.1186/1745-6215-15-160
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发表时间：
2014-05-08
期刊：
影响因子：
2.5
通讯作者：
Hobbs, F. D. Richard
中科院分区：
文献类型：
--
作者：
Hill, Nathan R.;Lasserson, Daniel;Hobbs, F. D. Richard
背景：慢性肾脏病(CKD)是一种常见的疾病，且患病率呈上升趋势。心血管疾病(CVD)是CKD发病和死亡的主要原因，尽管其表型与普通CVD人群不同。很少有治疗方法被证明能有效地改变CKD患者增加的CVD风险或肾功能减退率。越来越多的数据表明，醛固酮受体拮抗剂(ARA)可能对CKD的CV型患者提供心脏保护和延缓肾损害。因此，ARA在慢性肾脏病中的应用受到越来越多的提倡。然而，目前还没有关于ARA与肾脏或心血管疾病结局的大型研究。方法：这项研究是一项在初级保健中设置的前瞻性随机开放盲目终点(Probe)试验，在初级保健中，患者将主要通过他们的全科医生或现有的CKD名单进行识别。如果他们已被正式诊断为CKD 3b期，或从血液结果中有证据表明3b期CKD(EGFR 30-44毫升/分钟/1.73 m(2))，并满足其他纳入/排除标准，则将被邀请。患者将在常规护理的基础上每天随机服用一次螺内酯25 mg，或仅给予常规护理，并进行36个月的随访。讨论：BALAK D是一项探索性试验，旨在确定ARA对3b期CKD患者的死亡率和心血管结局(心血管疾病的发病或进展)的影响。
Background: Chronic 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.Methods: The 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 m(2)) 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.Discussion: BARACK 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.