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A 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 trial

Hayer, MK ; Edwards, NC ; Slinn, G ; Moody, WE ; Steeds, RP ; Ferro, CJ ; Price, AM ; Andujar, C ; Dutton, M ; Webster, R ; Webb, DJ ; Semple, S ; MacIntyre, I ; Melville, V ; Wilkinson, Ian Boden ; Hiemstra, Thomas Francois ; Wheeler, DC ; Herrey, A ; Grant, M ; Mehta, S ; Ives, N ; Townend, JN ; Apollo - University of Cambridge Repository; Apollo - University of Cambridge Repository

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  • Titolo:
    A 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 trial
  • Autore: Hayer, MK ; Edwards, NC ; Slinn, G ; Moody, WE ; Steeds, RP ; Ferro, CJ ; Price, AM ; Andujar, C ; Dutton, M ; Webster, R ; Webb, DJ ; Semple, S ; MacIntyre, I ; Melville, V ; Wilkinson, Ian Boden ; Hiemstra, Thomas Francois ; Wheeler, DC ; Herrey, A ; Grant, M ; Mehta, S ; Ives, N ; Townend, JN
  • Altro autore/Curatore: Apollo - University of Cambridge Repository; Apollo - University of Cambridge Repository
  • Editore: Apollo - University of Cambridge Repository
  • Anno: 2017
  • Note di contenuto: Background 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...
  • Tipo: Articolo
  • Identificativo: DOI: 10.17863/CAM.12368 ; ISSN: 0002-8703
  • Fonte: DataCite

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