The β-Blocker to lower cardiovascular dialysis events (BLOCADE) feasibility study: a randomized controlled trial

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. and Hawley, Carmel M. (2015) The β-Blocker to lower cardiovascular dialysis events (BLOCADE) feasibility study: a randomized controlled trial. American Journal of Kidney Diseases, 67 6: 902-911. doi:10.1053/j.ajkd.2015.10.029


Author 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.
Title The β-Blocker to lower cardiovascular dialysis events (BLOCADE) feasibility study: a randomized controlled trial
Journal name American Journal of Kidney Diseases   Check publisher's open access policy
ISSN 1523-6838
0272-6386
Publication date 2015-12-22
Sub-type Article (original research)
DOI 10.1053/j.ajkd.2015.10.029
Open Access Status Not Open Access
Volume 67
Issue 6
Start page 902
End page 911
Total pages 10
Place of publication Maryland Heights, MO, United States
Publisher W.B. Saunders
Collection year 2016
Language eng
Formatted abstract
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.
Keyword Adrenergic receptor blockade
Beta-blocker
Bradycardia
Cardiovascular disease (CVD)
Cardiovascular mortality
Carvedilol
Dialysis
Dilatrend
Drug tolerability
End-stage kidney disease (ESKD)
Feasibility study
Hemodialysis
Intradialytic hypotension (IDH)
Randomized controlled trial (RCT)
Study recruitment
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
 
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