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The rationale and design of the B eta‐blocker to LO wer CA rdiovascular D ialysis E vents ( BLOCADE ) F easibility S tudy
Author(s) -
Roberts Matthew A,
Pilmore Helen L,
Ierino Francesco L,
Badve Sunil V,
Cass Alan,
Garg Amit X,
Hawley Carmel M,
Isbel Nicole M,
Krum Henry,
Pascoe Elaine M,
Tonkin Andrew M,
Vergara Liza A,
Perkovic Vlado
Publication year - 2015
Publication title -
nephrology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.752
H-Index - 61
eISSN - 1440-1797
pISSN - 1320-5358
DOI - 10.1111/nep.12362
Subject(s) - carvedilol , medicine , placebo , dialysis , clinical endpoint , randomized controlled trial , beta blocker , clinical trial , incidence (geometry) , heart failure , alternative medicine , pathology , physics , optics
Aims The B eta‐blocker to LO wer CA rdiovascular D ialysis E vents ( BLOCADE ) F easibility S tudy aims to determine the feasibility of a large‐scale randomized controlled trial with clinical endpoints comparing the beta‐blocking agent carvedilol with placebo in patients receiving dialysis. Methods The BLOCADE F easibility S tudy is a randomized, double‐blind, placebo‐controlled, parallel group feasibility study comparing the beta‐blocking agent carvedilol with placebo. Patients receiving dialysis for ≥3 months and who are aged ≥50 years, or who are ≥18 years and have diabetes or cardiovascular disease, were eligible. The primary outcome was the proportion of participants who complete a 6‐week run‐in phase in which all participants received carvedilol titrated from 3.125 mg twice daily to 6.25 mg twice daily. Other measures included how many patients are screened, the proportion recruited, the overall recruitment rate, the proportion of participants who remain on study drug for 12 months and the incidence of intra‐dialytic hypotension while on randomized treatment. Results The BLOCADE F easibility S tudy commenced recruiting in M ay 2011 and involves 11 sites in A ustralia and N ew Z ealand. Conclusions The BLOCADE F easibility S tudy will inform the design of a larger clinical endpoint study to determine whether beta‐blocking agents provide benefit to patients receiving dialysis, and define whether such a study is feasible.