TY - JOUR
T1 - The β-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) feasibility study
T2 - A randomized controlled trial
AU - Roberts, Matthew A.
AU - Pilmore, Helen L
AU - Ierino, Francesco L
AU - Badve, Sunil V
AU - Cass, Alan
AU - Garg, Amit X
AU - Isbel, Nicole
AU - Krum, Henry
AU - Pascoe, Elaine M
AU - Perkovic, Vlado
AU - Scaria, Anish
AU - Tonkin, Andrew M.
AU - Vergara, Liza A
AU - Hawley, Carmel M.
AU - BLOCADE Study Collaborative Group
AU - Zhang, Lei
PY - 2016/6/1
Y1 - 2016/6/1
N2 - Background 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). Study Design Pilot RCT. Setting & Participants 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. Intervention After a 6-week run-in with the β-blocker carvedilol, we randomly assigned participants to treatment with carvedilol or placebo for 12 months. Outcomes & Measurements The prespecified primary outcome was the proportion of participants who tolerated carvedilol, 6.25 mg, twice daily during the run-in period. After randomization, we report participant withdrawal and the incidence of intradialytic hypotension (IDH). Results 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). Limitations Unable to recruit planned sample size. Conclusions 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.
AB - Background 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). Study Design Pilot RCT. Setting & Participants 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. Intervention After a 6-week run-in with the β-blocker carvedilol, we randomly assigned participants to treatment with carvedilol or placebo for 12 months. Outcomes & Measurements The prespecified primary outcome was the proportion of participants who tolerated carvedilol, 6.25 mg, twice daily during the run-in period. After randomization, we report participant withdrawal and the incidence of intradialytic hypotension (IDH). Results 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). Limitations Unable to recruit planned sample size. Conclusions 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.
KW - adrenergic receptor blockade
KW - Beta-blocker
KW - bradycardia
KW - cardiovascular disease (CVD)
KW - cardiovascular mortality
KW - carvedilol
KW - dialysis
KW - Dilatrend
KW - drug tolerability
KW - end-stage kidney disease (ESKD)
KW - feasibility study
KW - hemodialysis
KW - intradialytic hypotension (IDH)
KW - randomized controlled trial (RCT)
KW - study recruitment
UR - http://www.scopus.com/inward/record.url?scp=84951182519&partnerID=8YFLogxK
U2 - 10.1053/j.ajkd.2015.10.029
DO - 10.1053/j.ajkd.2015.10.029
M3 - Article
C2 - 26717861
AN - SCOPUS:84951182519
SN - 0272-6386
VL - 67
SP - 902
EP - 911
JO - American Journal of Kidney Diseases
JF - American Journal of Kidney Diseases
IS - 6
ER -
