The β-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial Academic Article uri icon

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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, 6.25mg, 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.

authors

  • Roberts, Matthew A
  • Pilmore, Helen L
  • Ierino, Francesco L
  • Badve, Sunil V
  • Cass, Alan
  • Garg, Amit
  • Isbel, Nicole M
  • Krum, Henry
  • Pascoe, Elaine M
  • Perkovic, Vlado
  • Scaria, Anish
  • Tonkin, Andrew M
  • Vergara, Liza A
  • Hawley, Carmel M
  • Roberts, Matthew A
  • Cass, Alan
  • Garg, Amit X
  • Hawley, Carmel M
  • Ierino, Francesco L
  • Isbel, Nicole M
  • Krum, Henry
  • Pascoe, Elaine M
  • Perkovic, Vlado
  • Pilmore, Helen L
  • Tonkin, Andrew M
  • Vergara, Liza A
  • Levin, Adeera
  • Hare, David
  • Martin, Andrew
  • Wheeler, David C
  • Fulcher, Gregory
  • Brown, Helen
  • Colquhoun, David
  • Korczyk, Dariusz
  • Mather, Amanda
  • Wong, Andrew
  • Roberts, Matthew
  • Ierino, Francesco
  • Bisscheroux, Pascal
  • Gillies, Alastair
  • Garvey, Leanne
  • Tan, Ken-Soon
  • Lennan, Erica
  • Isbel, Nicole
  • Pitkin, Markus
  • Ahearn, Karin
  • Carroll, Robert P
  • Scott, Eileen
  • Cooper, Bruce
  • Pearse, Jacqueline
  • Snelling, Paul
  • Burman, Jenny
  • Hand, Samantha
  • Pedagogos, Eugenie
  • Karschimkus, Connie
  • Pilmore, Helen
  • Pilmore, Andrew
  • Walker, Robert
  • Ellis, Gaye
  • Marshall, Mark R
  • Paul, Cecilia
  • Hawley, Carmel M
  • Johnson, David
  • Badve, Sunil
  • Cass, Alan
  • Helyar, Jean
  • Morrish, Alicia
  • Pascoe, Elaine M
  • Paul-Brent, Peta-Anne
  • Reidlinger, Donna
  • Scaria, Anish
  • Vergara, Liza A
  • Zhang, Lei

publication date

  • June 2016