The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study

Matthew Roberts, Helen Pilmore, FL Lerino, Sunil Badve, Alan Cass, Amit Garg, Carmel Hawley, Nicole Isbel, Henry Krum, Elaine Pascoe, Andrew Tonkin, Liza Vergara, Vlado Perkovic, BLOCADE Study Collaborative Group

    Research output: Contribution to journalArticle

    Abstract

    Aims: The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study 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 Feasibility Study 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 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.
    Original languageEnglish
    Pages (from-to)140-147
    Number of pages8
    JournalNephrology
    Volume20
    Issue number3
    DOIs
    Publication statusPublished - 2015

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  • Cite this

    Roberts, M., Pilmore, H., Lerino, FL., Badve, S., Cass, A., Garg, A., Hawley, C., Isbel, N., Krum, H., Pascoe, E., Tonkin, A., Vergara, L., Perkovic, V., & BLOCADE Study Collaborative Group (2015). The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study. Nephrology, 20(3), 140-147. https://doi.org/10.1111/nep.12362