Rationale and design of the myocardial microinjury and cardiac remodeling extension study in the sodium lowering in dialysate trial (Mac-SoLID study)

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aut.relation.articlenumber120en_NZ
aut.relation.journalBMC Nephrologyen_NZ
aut.relation.pages9
aut.relation.volume15en_NZ
aut.researcherVandal, Alain
dc.contributor.authorDunlop, JLen_NZ
dc.contributor.authorVandal, Aen_NZ
dc.contributor.authorde Zoysa, JRen_NZ
dc.contributor.authorGabriel, RSen_NZ
dc.contributor.authorGerber, LMen_NZ
dc.contributor.authorHaloob, IAen_NZ
dc.contributor.authorHood, CJen_NZ
dc.contributor.authorIrvine, JHen_NZ
dc.contributor.authorMatheson, PJen_NZ
dc.contributor.authorMcGregor, DORen_NZ
dc.contributor.authorRabindranath, KSen_NZ
dc.contributor.authorSchollum, JBWen_NZ
dc.contributor.authorSemple, DJen_NZ
dc.contributor.authorMarshall, MRen_NZ
dc.date.accessioned2018-09-10T04:18:01Z
dc.date.available2018-09-10T04:18:01Z
dc.date.copyright2014en_NZ
dc.date.issued2014en_NZ
dc.description.abstractBackground: The Sodium Lowering in Dialysate (SoLID) trial is an ongoing a multi-center, prospective, randomised, single-blind (assessor), controlled, parallel assignment clinical trial, enrolling 96 home and self-care hemodialysis (HD) patients from 7 centers in New Zealand. The trial will evaluate the hypothesis that lower dialysate [Na+] during HD results in lower left ventricular (LV) mass. Since it’s inception, observational evidence has suggested increased mortality risk with lower dialysate [Na+], possibly due to exacerbation of intra-dialytic hypotension and subsequent myocardial micro-injury. The Myocardial Micro-injury and Cardiac Remodeling Extension Study in the Sodium Lowering In Dialysate Trial (Mac-SoLID study) aims to determine whether lower dialysate [Na+] results in (i) increased levels of high-sensitivity Troponin T (hsTnT), a well-established marker of intra-dialytic myocardial micro-injury in HD populations, and (ii) increased fixed LV segmental wall motion abnormalities, a marker of recurrent myocardial stunning and micro-injury, and (iii) detrimental changes in LV geometry due to maladaptive homeostatic mechanisms. Methods/design: The SoLID trial and the Mac-SoLID study are funded by the Health Research Council of New Zealand. Key exclusion criteria: patients who dialyse > 3.5 times per week, pre-dialysis serum sodium <135 mM, and maintenance haemodiafiltration. In addition, some medical conditions, treatments or participation in other dialysis trials that contraindicate the study intervention or confound its effects, will be exclusion criteria. The intervention and control groups will receive dialysate sodium 135 mM and 140 mM respectively, for 12 months. The primary outcome measure for the Mac-SOLID study is repeated measures of [hsTnT] at 0, 3, 6, 9, and 12 months. The secondary outcomes will be assessed using cardiac magnetic resonance imaging (MRI), and comprise LV segmental wall motion abnormality scores, LV mass to volume ratio and patterns of LV remodeling at 0 and 12 months. Discussion: The Mac-SoLID study enhances and complements the SoLID trial. It tests whether potential gains in cardiovascular health (reduced LV mass) which low dialysate [Na+] is expected to deliver, are counteracted by deterioration in cardiovascular health through alternative mechanisms, namely repeated LV stunning and micro-injury. (Continued from previous page) Trial registration: Australian and New Zealand Clinical Trials Registry number: ACTRN12611000975998. Keywords: Home hemodialysis, Self-care hemodialysis, Dialysis, Left ventricular mass, Left ventricular remodelling, Myocardial stunning, Sodium, Blood pressure, Intra-dialytic hypotension, Dialysateen_NZ
dc.identifier.citationBMC Nephrology, 15(1), 120.
dc.identifier.doi10.1186/1471-2369-15-120en_NZ
dc.identifier.issn1471-2369en_NZ
dc.identifier.urihttps://hdl.handle.net/10292/11798
dc.publisherBioMed Central Ltd
dc.relation.urihttps://bmcnephrol.biomedcentral.com/articles/10.1186/1471-2369-15-120
dc.rights© Dunlop et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
dc.rights.accessrightsOpenAccessen_NZ
dc.subjectHome dialysisen_NZ
dc.subjectSelf-care dialysisen_NZ
dc.subjectDialysisen_NZ
dc.subjectLeft ventricular massen_NZ
dc.subjectLeft ventricular remodellingen_NZ
dc.subjectMyocardial stuningen_NZ
dc.subjectSodiumen_NZ
dc.subjectBlood pressureen_NZ
dc.subjectintra-dialytic hypotensionen_NZ
dc.subjectDialysateen_NZ
dc.titleRationale and design of the myocardial microinjury and cardiac remodeling extension study in the sodium lowering in dialysate trial (Mac-SoLID study)en_NZ
dc.typeJournal Article
pubs.elements-id185659
pubs.organisational-data/AUT
pubs.organisational-data/AUT/Health & Environmental Science
pubs.organisational-data/AUT/PBRF
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences
pubs.organisational-data/AUT/PBRF/PBRF Health and Environmental Sciences/HY Public Health & Psychosocial Studies 2018 PBRF
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