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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. (2016). The β-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial. American Journal of Kidney Diseases,67(6):902-911.

Document type: Journal Article
Citation counts: Altmetric Score Altmetric Score is 3
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IRMA ID 81144320xPUB201
Title The β-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial
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.
Journal Name American Journal of Kidney Diseases
Publication Date 2016
Volume Number 67
Issue Number 6
ISSN 0272-6386   (check CDU catalogue open catalogue search in new window)
Scopus ID 2-s2.0-84951182519
Start Page 902
End Page 911
Total Pages 10
Place of Publication United States
Publisher W.B. Saunders Co.
HERDC Category C1 - Journal Article (DIISR)
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.
DOI http://dx.doi.org/10.1053/j.ajkd.2015.10.029   (check subscription with CDU E-Gateway service for CDU Staff and Students  check subscription with CDU E-Gateway in new window)
 
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