TY - JOUR AU - Cass Alan AU - Hawley C. AU - Pilmore H. AU - Garg A. AU - Pascoe E. AU - Ierino F. AU - Krum H. AU - Roberts M. AU - Badve S. AU - Vergara L. AU - Isbel N. AU - Tonki A. AU - Perkovic Vlado AB -
AIMS: The BLOCADE Feasibility Study aims to determine the feasibility of a large-scale randomised controlled trial with clinical endpoints comparing the beta-blocking agent carvedilol to placebo in patients receiving dialysis. METHODS: The BLOCADE Feasibility Study is a randomised, double blind, placebo-controlled, parallel group feasibility study comparing the beta-blocking agent carvedilol to placebo. Patients receiving dialysis for >/=3 months and who are aged >/=50 years, or who are >/=18 years and have diabetes or cardiovascular disease, are eligible. The primary outcome is the proportion of participants who complete a 6-week Run-in phase in which all participants receive carvedilol titrated from 3.125mg twice daily to 6.25mg twice daily. Other measures include 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 randomised treatment. RESULTS: The BLOCADE Feasibility Study commenced recruiting in May 2011 and involves 11 sites in Australia and New Zealand. CONCLUSIONS: The BLOCADE Feasibility Study 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.
AD - Department of Renal Medicine, Eastern Health Clinical School, Monash University, Melbourne, Australia. AN - 25382452 BT - Nephrology (Carlton) DP - NLM ET - 2014/11/11 IS - 3 LA - Eng LB - R&M N1 - Roberts, Matthew AAIMS: The BLOCADE Feasibility Study aims to determine the feasibility of a large-scale randomised controlled trial with clinical endpoints comparing the beta-blocking agent carvedilol to placebo in patients receiving dialysis. METHODS: The BLOCADE Feasibility Study is a randomised, double blind, placebo-controlled, parallel group feasibility study comparing the beta-blocking agent carvedilol to placebo. Patients receiving dialysis for >/=3 months and who are aged >/=50 years, or who are >/=18 years and have diabetes or cardiovascular disease, are eligible. The primary outcome is the proportion of participants who complete a 6-week Run-in phase in which all participants receive carvedilol titrated from 3.125mg twice daily to 6.25mg twice daily. Other measures include 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 randomised treatment. RESULTS: The BLOCADE Feasibility Study commenced recruiting in May 2011 and involves 11 sites in Australia and New Zealand. CONCLUSIONS: The BLOCADE Feasibility Study 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.
PY - 2015 SE - 140-7 SN - 1440-1797 (Electronic)