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; null BLOCADE Study Collaborative Group

doi:10.1111/nep.12362

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 journal › Article › peer-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 language	English
Pages (from-to)	140-147
Number of pages	8
Journal	Nephrology
Volume	20
Issue number	3
DOIs	https://doi.org/10.1111/nep.12362
Publication status	Published - 2015

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10.1111/nep.12362

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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, 20(3), 140-147. https://doi.org/10.1111/nep.12362

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

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.",

keywords = "brain natriuretic peptide, carvedilol, placebo, beta adrenergic receptor blocking agent, carbazole derivative, propanolamine derivative, adult, aged, Article, Australia and New Zealand, blood pressure measurement, cardiovascular disease, controlled study, diabetes mellitus, double blind procedure, drug dose titration, drug efficacy, drug tolerability, echocardiography, feasibility study, female, hemodialysis, human, hypotension, incidence, laboratory test, major clinical study, male, multicenter study, outcome assessment, peritoneal dialysis, priority journal, randomized controlled trial, study design, adverse effects, Australia, Cardiovascular Diseases, clinical protocol, clinical trial, complication, Kidney Failure, Chronic, medication compliance, methodology, middle aged, New Zealand, patient selection, renal replacement therapy, sample size, time, treatment outcome, Adrenergic beta-Antagonists, Carbazoles, Clinical Protocols, Double-Blind Method, Feasibility Studies, Female, Humans, Male, Medication Adherence, Middle Aged, Patient Selection, Peritoneal Dialysis, Propanolamines, Renal Dialysis, Research Design, Sample Size, Time Factors, Treatment Outcome",

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",

doi = "10.1111/nep.12362",

language = "English",

volume = "20",

pages = "140--147",

journal = "Nephrology",

issn = "1320-5358",

publisher = "Wiley-Blackwell",

number = "3",

}

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

TY - JOUR

T1 - The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study

AU - Roberts, Matthew

AU - Pilmore, Helen

AU - Lerino, FL

AU - Badve, Sunil

AU - Cass, Alan

AU - Garg, Amit

AU - Hawley, Carmel

AU - Isbel, Nicole

AU - Krum, Henry

AU - Pascoe, Elaine

AU - Tonkin, Andrew

AU - Vergara, Liza

AU - Perkovic, Vlado

AU - BLOCADE Study Collaborative Group, null

PY - 2015

Y1 - 2015

N2 - 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.

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.

KW - brain natriuretic peptide

KW - carvedilol

KW - placebo

KW - beta adrenergic receptor blocking agent

KW - carbazole derivative

KW - propanolamine derivative

KW - adult

KW - aged

KW - Article

KW - Australia and New Zealand

KW - blood pressure measurement

KW - cardiovascular disease

KW - controlled study

KW - diabetes mellitus

KW - double blind procedure

KW - drug dose titration

KW - drug efficacy

KW - drug tolerability

KW - echocardiography

KW - feasibility study

KW - female

KW - hemodialysis

KW - human

KW - hypotension

KW - incidence

KW - laboratory test

KW - major clinical study

KW - male

KW - multicenter study

KW - outcome assessment

KW - peritoneal dialysis

KW - priority journal

KW - randomized controlled trial

KW - study design

KW - adverse effects

KW - Australia

KW - Cardiovascular Diseases

KW - clinical protocol

KW - clinical trial

KW - complication

KW - Kidney Failure, Chronic

KW - medication compliance

KW - methodology

KW - middle aged

KW - New Zealand

KW - patient selection

KW - renal replacement therapy

KW - sample size

KW - time

KW - treatment outcome

KW - Adrenergic beta-Antagonists

KW - Carbazoles

KW - Clinical Protocols

KW - Double-Blind Method

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Male

KW - Medication Adherence

KW - Middle Aged

KW - Patient Selection

KW - Peritoneal Dialysis

KW - Propanolamines

KW - Renal Dialysis

KW - Research Design

KW - Sample Size

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1111/nep.12362

DO - 10.1111/nep.12362

M3 - Article

VL - 20

SP - 140

EP - 147

JO - Nephrology

JF - Nephrology

SN - 1320-5358

IS - 3

ER -

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

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