Journal article
Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial
- Abstract:
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Background: Chronic kidney disease (CKD) is common and increasing in prevalence. Cardiovascular disease (CVD) is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway.
Methods: The study is a prospective randomised open blinded endpoint (PROBE) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30-44 mL/min/1.73 m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25 mg once daily in addition to routine care or routine care alone and followed-up for 36 months.
Discussion: BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of CVD) in patients with stage 3b CKD.
Trial registration: EudraCT: 2012-002672-13
ISRTN: ISRCTN44522369
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Corrected version of record, pdf, 795.6KB, Terms of use)
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(Preview, Version of record, pdf, 333.5KB, Terms of use)
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- Publisher copy:
- 10.1186/1745-6215-15-160
Authors
- Publisher:
- BioMed Central
- Journal:
- Trials More from this journal
- Volume:
- 15
- Issue:
- 1
- Article number:
- 160
- Publication date:
- 2014-05-08
- Acceptance date:
- 2014-04-22
- DOI:
- EISSN:
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1745-6215
- ISSN:
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1745-6215
- Language:
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English
- Keywords:
- Subjects:
- Pubs id:
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464890
- UUID:
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uuid:13371a90-9c42-467c-9064-fa4f243ef9ff
- Local pid:
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pubs:464890
- Source identifiers:
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464890
- Deposit date:
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2014-05-28
- ARK identifier:
Terms of use
- Copyright holder:
- Hill et al.
- Copyright date:
- 2014
- Rights statement:
- © 2014 Hill et al.; licensee BioMed Central Ltd. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The Creative Commons Public Domain Dedication waiver applies to the data made available in this article, unless otherwise stated in a credit line to the data.
- Notes:
- A Correction to this article was published on 12 December 2022. See: https://doi.org/10.1186/s13063-022-06972-9.
- Licence:
- CC Attribution (CC BY)
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