The β-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial

Garg, Amit X.; Krum, Henry; Perkovic, Vlado; Tonkin, Andrew; Levin, Adeera; Hare, David; Martin, Andrew; Wheeler, David C.; Fulcher, Gregory; Brown, Helen; Colquhoun, David; Korczyk, Dariusz; Mather, Amanda; Wong, Andrew; Roberts, Matthew A; Ierino, Francesco L.; Bisscheroux, Pascal; Gillies, Alastair; Garvey, Leanne; Tan, Ken‐Soon; Lennan, Erica; Isbel, Nicole M.; Pitkin, M.; Ahearn, Karin; Carroll, Robert; Scott, Eileen; Cooper, Bruce A.; Pearse, Jacqueline; Snelling, Paul; Burman, Jenny; Hand, Samantha; Pedagogos, Eugenie; Karschimkus, Connie; Pilmore, Helen; Pilmore, Andrew; Walker, Robert; Ellis, Gaye; Marshall, Mark R.; Paul, Cecilia; Hawley, Carmel M.; Johnson, David G.; Badve, Sunil V.; Cass, Alan; Helyar, Jean; Morrish, Alicia T.; Pascoe, Elaine M.; Paul‐Brent, Peta‐Anne; Reidlinger, Donna; Scaria, Anish; Vergara, Liza A.; Zhang, Lei

doi:10.1053/j.ajkd.2015.10.029

Cited by 42 publications

(51 citation statements)

References 29 publications

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“…Recruitment of participants to the BLOCADE Feasibility Study and baseline characteristics of all participants were described in the main report [21]. Seventy-two participants entered the run-in phase of whom 23 failed to complete this, leaving 49 participants randomized to carvedilol (n=26) or placebo (n=23).…”

Section: Resultsmentioning

confidence: 99%

“…The BLOCADE Feasibility Study was a randomized, double-blind, placebo-controlled, parallel group study in which patients with ESKD receiving dialysis were randomized 1: 1 to receive carvedilol or placebo (up to 25mg twice daily) for 12 months [21]. This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12609000174280) and the University of Queensland Medical Research Ethics Committee approved the study (Project Number: 2009000775), as did the Ethics Committees at individual sites.…”

Section: Methodsmentioning

confidence: 99%

“…Inclusion and exclusion criteria were described previously [21]. Briefly, ESKD patients receiving either hemodialysis or peritoneal dialysis were approached to participate if they were aged 50 years or more, or aged 18 years or more with co-morbid diabetes and/or cardiovascular disease, and their treating physician agreed to them being randomized to a BBA or placebo.…”

Section: Methodsmentioning

confidence: 99%

“…The planned sample size was based on the feasibility outcome for the original study [21] and not these biomarker outcomes.…”

Section: Methodsmentioning

confidence: 99%

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Carvedilol and Cardiac Biomarkers in Dialysis Patients: Secondary Analysis of a Randomized Controlled Trial

Roberts

Darssan

Badve³

et al. 2017

Kidney Blood Press Res

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Background/Aims: Cardiac biomarkers are associated with cardiac abnormalities and adverse outcomes in dialysis patients. Our aim was to report the effect of the beta-blocker carvedilol on cardiac biomarkers in adult dialysis patients. Methods: The Beta-Blocker to Lower Cardiovascular Dialysis Events Feasibility Study was a randomized controlled trial comparing carvedilol to placebo. Serum and plasma were collected before the run-in, then 6 and 12 months post-randomization to measure B-type Natriuretic Peptide (BNP), N-terminal BNP (NT-ProBNP), high-sensitivity cardiac troponins I (hs-TnI) and T (hs-TnT), and galectin-3. Left ventricular global longitudinal strain (GLS) was measured by echocardiography at baseline. Results: Seventy-two participants were recruited of whom 49 completed the run-in and were randomized to carvedilol (n=26) or placebo (n=23). Baseline echocardiography demonstrated median (inter-quartile range) GLS of -14.27% (-16.63 to -11.93). NTproBNP and hs-TnT correlated with GLS (Spearman’s rho=0.34 [p=0.018] and rho=0.28 [p=0.049], respectively). Median change scores from baseline to 12 months did not differ significantly between participants with complete biomarker data randomized to carvedilol (n=15) or placebo (n=16) for any biomarkers. Conclusions: NT-proBNP and hs-TnT were associated with GLS. However, changes in levels of the biomarkers from baseline to 12 months were not different between groups randomized to carvedilol and placebo.

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…The planned sample size was based on the feasibility outcome for the original study [21] and not these biomarker outcomes.…”

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Carvedilol and Cardiac Biomarkers in Dialysis Patients: Secondary Analysis of a Randomized Controlled Trial

Roberts

Darssan

Badve³

et al. 2017

Kidney Blood Press Res

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“…These findings have yet to be replicated. Indeed, a recently published feasibility study demonstrated significant challenges with recruiting dialysis patients into β-blocker intervention studies and emphasized the need for pragmatic trial methodologies [57].…”

Section: Aspects In Dialysismentioning

confidence: 99%

Cardiovascular Disease in Dialysis Patients

Jegatheesan¹,

Yang²,

Krishnasamy³

et al. 2018

Aspects in Dialysis

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Cardiovascular disease (CVD) is highly prevalent in the dialysis population, affecting up to 60% of cohorts. Cardiovascular mortality rates are reported to be ~14 per 100 patient-years, which are 10-to 20-fold greater than those of age-and gender-matched controls. CVD is the primary cause of death in up to 40% of dialysis patients in Australia, New Zealand and the United States. Dialysis patients endure a greater burden of both traditional risk factors for CVD and risk factors related to loss of kidney function that may account for the higher CVD morbidity and mortality. Many cardiology guidelines include chronic kidney disease (CKD) and end-stage kidney disease (ESKD) as coronary heart disease (CHD) risk equivalents. It is therefore important for clinicians to both recognise and optimise the cardiovascular health of patients receiving maintenance dialysis. This chapter will focus on risk factor modification, screening and prevention of CVD in dialysis patients.

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Pharmacological interventions for heart failure in people with chronic kidney disease

Lunney

Ruospo

Natale

et al. 2020

Cochrane Database of Systematic Reviews

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The β-Blocker to Lower Cardiovascular Dialysis Events (BLOCADE) Feasibility Study: A Randomized Controlled Trial

Cited by 42 publications

References 29 publications

Carvedilol and Cardiac Biomarkers in Dialysis Patients: Secondary Analysis of a Randomized Controlled Trial

Carvedilol and Cardiac Biomarkers in Dialysis Patients: Secondary Analysis of a Randomized Controlled Trial

Cardiovascular Disease in Dialysis Patients

Pharmacological interventions for heart failure in people with chronic kidney disease

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