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dc.contributor.authorHayer, MKen
dc.contributor.authorEdwards, NCen
dc.contributor.authorSlinn, Gen
dc.contributor.authorMoody, WEen
dc.contributor.authorSteeds, RPen
dc.contributor.authorFerro, CJen
dc.contributor.authorPrice, AMen
dc.contributor.authorAndujar, Cen
dc.contributor.authorDutton, Men
dc.contributor.authorWebster, Ren
dc.contributor.authorWebb, DJen
dc.contributor.authorSemple, Sen
dc.contributor.authorMacIntyre, Ien
dc.contributor.authorMelville, Ven
dc.contributor.authorWilkinson, Ianen
dc.contributor.authorHiemstra, Thomasen
dc.contributor.authorWheeler, DCen
dc.contributor.authorHerrey, Aen
dc.contributor.authorGrant, Men
dc.contributor.authorMehta, Sen
dc.contributor.authorIves, Nen
dc.contributor.authorTownend, JNen
dc.date.accessioned2017-08-31T08:44:03Z
dc.date.available2017-08-31T08:44:03Z
dc.date.issued2017-09-01en
dc.identifier.issn0002-8703
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/266966
dc.description.abstractBackground Chronic kidney disease (CKD) is associated with increased left ventricular (LV) mass and arterial stiffness. In a previous trial, spironolactone improved these end points compared with placebo in subjects with early-stage CKD, but it is not known whether these effects were specific to the drug or secondary to blood pressure lowering. Aim The aim was to investigate the hypothesis that spironolactone is superior to chlorthalidone in the reduction of LV mass while exerting similar effects on blood pressure. Design This is a multicenter, prospective, randomized, open-label, blinded end point clinical trial initially designed to compare the effects of 40 weeks of treatment with spironolactone 25 mg once daily to chlorthalidone 25 mg once daily on the co-primary end points of change in pulse wave velocity and change in LV mass in 350 patients with stages 2 and 3 CKD on established treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. Because of slow recruitment rates, it became apparent that it would not be possible to recruit this sample size within the funded time period. The study design was therefore changed to one with a single primary end point of LV mass requiring 150 patients. Recruitment was completed on 31 December 2016, at which time 154 patients had been recruited. Investigations included cardiac magnetic resonance imaging, applanation tonometry, 24-hour ambulatory blood pressure monitoring, and laboratory tests. Subjects are assessed before and after 40 weeks of randomly allocated drug therapy and at 46 weeks after discontinuation of the study drug.
dc.description.sponsorshipWe acknowledge the assistance and facilities provided by the NIHR/Wellcome Trust Birmingham Clinical Research Facility.
dc.languageengen
dc.publisherElsevier
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internationalen
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
dc.titleA randomized, multicenter, open-label, blinded end point trial comparing the effects of spironolactone to chlorthalidone on left ventricular mass in patients with early-stage chronic kidney disease: Rationale and design of the SPIRO-CKD trialen
dc.typeArticle
prism.endingPage46
prism.publicationDate2017en
prism.publicationNameAmerican Heart Journalen
prism.startingPage37
prism.volume191en
dc.identifier.doi10.17863/CAM.12368
dcterms.dateAccepted2017-05-18en
rioxxterms.versionofrecord10.1016/j.ahj.2017.05.008en
rioxxterms.versionVoRen
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/en
rioxxterms.licenseref.startdate2017-09-01en
dc.contributor.orcidWilkinson, Ian [0000-0001-6598-9399]
dc.contributor.orcidHiemstra, Thomas [0000-0002-2115-8689]
dc.identifier.eissn1097-6744
rioxxterms.typeJournal Article/Reviewen
pubs.funder-project-idBritish Heart Foundation (via University of Birmingham) (RG_13-013)
pubs.funder-project-idBritish Heart Foundation (FS/12/8/29377)
cam.issuedOnline2017-05-24en


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Attribution-NonCommercial-NoDerivatives 4.0 International
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