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Title: The β-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial.
Austin Authors: Roberts, Matthew A;Pilmore, Helen L;Ierino, Francesco L;Badve, Sunil V;Cass, Alan;Garg, Amit X;Isbel, Nicole M;Krum, Henry;Pascoe, Elaine M;Perkovic, Vlado;Scaria, Anish;Tonkin, Andrew M;Vergara, Liza A;Hawley, Carmel M
Affiliation: Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia
Cardiovascular Research Unit, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia
Department of Nephrology, St George Hospital, Sydney, Australia
Department of Medicine, University of Melbourne, Melbourne, Australia
Department of Nephrology, Austin Health, Heidelberg, Victoria, Australia
Division of Nephrology, Department of Medicine, Western University, London, Canada
Department of Renal Medicine, Eastern Health Clinical School, Monash University, Melbourne, Australia
Department of Renal Medicine, Auckland City Hospital, Auckland, New Zealand
George Institute for Global Health, University of Sydney, Sydney, Australia
Australasian Kidney Trials Network, The University of Queensland, Brisbane, Australia
Centre of Cardiovascular Research and Education in Therapeutics, Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia
Department of Nephrology, Princess Alexandra Hospital, Brisbane, Australia
Issue Date: Jun-2016 2015-12-22
Publication information: American journal of kidney diseases : the official journal of the National Kidney Foundation 2016; 67(6): 902-11
Abstract: β-Blocking agents reduce cardiovascular mortality in patients with heart disease, but their potential benefit in dialysis patients is unclear. We aimed to determine the feasibility of a randomized controlled trial (RCT). Pilot RCT. Patients who received dialysis for 3 or more months and were 50 years or older (or ≥18 years with diabetes or cardiovascular disease) were recruited from 11 sites in Australia and New Zealand. We aimed to recruit 150 participants. After a 6-week run-in with the β-blocker carvedilol, we randomly assigned participants to treatment with carvedilol or placebo for 12 months. The prespecified primary outcome was the proportion of participants who tolerated carvedilol, 6.25mg, twice daily during the run-in period. After randomization, we report participant withdrawal and the incidence of intradialytic hypotension (IDH). Of 1,443 patients screened, 354 were eligible, 91 consented, and 72 entered the run-in stage. 49 of 72 run-in participants (68%; 95% CI, 57%-79%) achieved the primary outcome. 5 of the 23 withdrawals from run-in were attributable to bradycardia or hypotension. After randomization, 10 of 26 allocated to carvedilol and 4 of 23 allocated to placebo withdrew. 4 participants randomly assigned to carvedilol withdrew because of bradycardia or hypotension. Overall, there were 4 IDH events per 100 hemodialysis sessions; in participants allocated to carvedilol versus placebo, respectively, there were 7 versus 2 IDH events per 100 hemodialysis sessions (P=0.1) in the 2 weeks immediately following a dose increase and 4 versus 3 IDH events per 100 hemodialysis sessions after no dose increase (P=0.7). Unable to recruit planned sample size. Recruiting patients receiving dialysis to an RCT of β-blocker versus placebo will prove challenging. Possible solutions include international collaboration and exploring novel trial designs such as a registry-based RCT.
DOI: 10.1053/j.ajkd.2015.10.029
Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation
PubMed URL: 26717861
Type: Journal Article
Subjects: Beta-blocker
adrenergic receptor blockade
cardiovascular disease (CVD)
cardiovascular mortality
drug tolerability
end-stage kidney disease (ESKD)
feasibility study
intradialytic hypotension (IDH)
randomized controlled trial (RCT)
study recruitment
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