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 journalArticleResearchpeer-review

    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

    Fingerprint

    Feasibility Studies
    Dialysis
    Placebos
    New Zealand
    Hypotension
    Cardiovascular Diseases
    Randomized Controlled Trials
    Incidence
    Pharmaceutical Preparations
    carvedilol

    Cite this

    Roberts, M., Pilmore, H., Lerino, FL., Badve, S., Cass, A., Garg, A., ... 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
    Roberts, Matthew ; Pilmore, Helen ; Lerino, FL ; Badve, Sunil ; Cass, Alan ; Garg, Amit ; Hawley, Carmel ; Isbel, Nicole ; Krum, Henry ; Pascoe, Elaine ; Tonkin, Andrew ; Vergara, Liza ; Perkovic, Vlado ; BLOCADE Study Collaborative Group. / The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study. In: Nephrology. 2015 ; Vol. 20, No. 3. pp. 140-147.
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    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.",
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    author = "Matthew Roberts and Helen Pilmore and FL Lerino and Sunil Badve and Alan Cass and Amit Garg and Carmel Hawley and Nicole Isbel and Henry Krum and Elaine Pascoe and Andrew Tonkin and Liza Vergara and Vlado Perkovic and {BLOCADE Study Collaborative Group}",
    year = "2015",
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    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, vol. 20, no. 3, pp. 140-147. https://doi.org/10.1111/nep.12362

    The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study. / Roberts, Matthew; Pilmore, Helen; Lerino, FL; Badve, Sunil; Cass, Alan; Garg, Amit; Hawley, Carmel; Isbel, Nicole; Krum, Henry; Pascoe, Elaine; Tonkin, Andrew; Vergara, Liza; Perkovic, Vlado; BLOCADE Study Collaborative Group.

    In: Nephrology, Vol. 20, No. 3, 2015, p. 140-147.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

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    AU - Pilmore, Helen

    AU - Lerino, FL

    AU - Badve, Sunil

    AU - Cass, Alan

    AU - Garg, Amit

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    AU - Isbel, Nicole

    AU - Krum, Henry

    AU - Pascoe, Elaine

    AU - Tonkin, Andrew

    AU - Vergara, Liza

    AU - Perkovic, Vlado

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    AB - 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.

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