The b-Blocker to Lower XXXX Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial.

@entity1 @entity6 @entity1405 @entity23 @entity299 @entity551 @entity1168 @entity65
BACKGROUND: b-Blocking agents reduce @entity65 in @entity1 with @entity299 , but their potential benefit in dialysis @entity1 is unclear. We aimed to determine the feasibility of a @entity23 ( @entity23 ). STUDY DESIGN: Pilot @entity23 . SETTING _ @entity1 : @entity1 who received dialysis for 3 or more months and were 50 years or older (or  >= 18 years with @entity6 or @entity65 ) were recruited from 11 sites in Australia and New Zealand. We aimed to recruit 150 @entity1 . INTERVENTION: After a 6-week run-in with the b-blocker @entity1405 , we randomly assigned @entity1 to treatment with @entity1405 or placebo for 12 months. OUTCOMES _ MEASUREMENTS: The prespecified primary outcome was the proportion of @entity1 who tolerated @entity1405 , 6.25mg, twice daily during the run-in period. After randomization, we report @entity1 withdrawal and the incidence of @entity551 ( @entity551 ). RESULTS: Of 1,443 @entity1 screened, 354 were eligible, 91 consented, and 72 entered the run-in stage. 49 of 72 run-in @entity1 (68%; 95% CI, 57%-79%) achieved the primary outcome. 5 of the 23 withdrawals from run-in were attributable to @entity1168 or @entity551 . After randomization, 10 of 26 allocated to @entity1405 and 4 of 23 allocated to placebo withdrew. 4 @entity1 randomly assigned to @entity1405 withdrew because of @entity1168 or @entity551 . Overall, there were 4 @entity551 events per 100 hemodialysis sessions; in @entity1 allocated to @entity1405 versus placebo, respectively, there were 7 versus 2 @entity551 events per 100 hemodialysis sessions (P=0.1) in the 2 weeks immediately following a dose increase and 4 versus 3 @entity551 events per 100 hemodialysis sessions after no dose increase (P=0.7). LIMITATIONS: Unable to recruit planned sample size. CONCLUSIONS: Recruiting @entity1 receiving dialysis to an @entity23 of b-blocker versus placebo will prove challenging. Possible solutions include international collaboration and exploring novel trial designs such as a registry-based @entity23 .
