Roberts Matthew A, Pilmore Helen L, Ierino Francesco L, Badve Sunil V, Cass Alan, Garg Amit X, Hawley Carmel M, Isbel Nicole M, Krum Henry, Pascoe Elaine M, Tonkin Andrew M, Vergara Liza A, Perkovic Vlado
Department of Renal Medicine, Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia.
Nephrology (Carlton). 2015 Mar;20(3):140-7. doi: 10.1111/nep.12362.
The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study aims to determine the feasibility of a large-scale randomized controlled trial with clinical endpoints comparing the beta-blocking agent carvedilol with placebo in patients receiving dialysis.
The BLOCADE Feasibility Study is a randomized, double-blind, placebo-controlled, parallel group feasibility study comparing the beta-blocking agent carvedilol with placebo. Patients receiving dialysis for ≥3 months and who are aged ≥50 years, or who are ≥18 years and have diabetes or cardiovascular disease, were eligible. The primary outcome was the proportion of participants who complete a 6-week run-in phase in which all participants received carvedilol titrated from 3.125 mg twice daily to 6.25 mg twice daily. Other measures included how many patients are screened, the proportion recruited, the overall recruitment rate, the proportion of participants who remain on study drug for 12 months and the incidence of intra-dialytic hypotension while on randomized treatment.
The BLOCADE Feasibility Study commenced recruiting in May 2011 and involves 11 sites in Australia and New Zealand.
The BLOCADE Feasibility Study will inform the design of a larger clinical endpoint study to determine whether beta-blocking agents provide benefit to patients receiving dialysis, and define whether such a study is feasible.
β受体阻滞剂降低心血管透析事件（BLOCADE）可行性研究旨在确定一项大规模随机对照试验的可行性，该试验以临床终点比较β受体阻滞剂卡维地洛与安慰剂在接受透析患者中的疗效。
BLOCADE可行性研究是一项随机、双盲、安慰剂对照、平行组可行性研究，比较β受体阻滞剂卡维地洛与安慰剂。接受透析≥3个月且年龄≥50岁，或年龄≥18岁且患有糖尿病或心血管疾病的患者符合条件。主要结局是完成6周导入期的参与者比例，在此期间所有参与者接受从每日两次3.125mg滴定至每日两次6.25mg的卡维地洛治疗。其他指标包括筛查的患者数量、招募比例、总体招募率、服用研究药物12个月的参与者比例以及随机治疗期间透析中低血压的发生率。
BLOCADE可行性研究于2011年5月开始招募，涉及澳大利亚和新西兰的11个地点。
BLOCADE可行性研究将为设计一项更大规模的临床终点研究提供信息，以确定β受体阻滞剂是否能使接受透析的患者获益，并确定这样一项研究是否可行。
