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Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial
BACKGROUND: Chronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition. The use of low-dose spironolactone has previously been show...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2014
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4113230/ https://www.ncbi.nlm.nih.gov/pubmed/24886272 http://dx.doi.org/10.1186/1745-6215-15-158 |
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author | Ng, Khai P Jain, Poorva Heer, Gurdip Redman, Val Chagoury, Odette L Dowswell, George Greenfield, Sheila Freemantle, Nick Townend, Jonathan N Gill, Paramjit S McManus, Richard J Ferro, Charles J |
author_facet | Ng, Khai P Jain, Poorva Heer, Gurdip Redman, Val Chagoury, Odette L Dowswell, George Greenfield, Sheila Freemantle, Nick Townend, Jonathan N Gill, Paramjit S McManus, Richard J Ferro, Charles J |
author_sort | Ng, Khai P |
collection | PubMed |
description | BACKGROUND: Chronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition. The use of low-dose spironolactone has previously been shown to improve arterial stiffness and reduce left ventricular mass safely in early-stage chronic kidney disease in the context of careful monitoring at a university hospital. However, the majority of patients with chronic kidney disease are managed by their general practitioners in the community. It is not known whether similar beneficial effects can be achieved safely using spironolactone in the primary care setting. The aim of this study is to determine whether low-dose spironolactone can safely lower arterial stiffness in patients with stage 3 chronic kidney disease in the primary care setting. METHODS/DESIGN: STOP-CKD is a multicentre, prospective, randomized, double-blind, placebo-controlled pilot trial of 240 adult patients with stage 3 chronic kidney disease recruited from up to 20 general practices in South Birmingham, England. Participants will be randomly allocated using a secured web-based computer randomization system to receive either spironolactone 25 mg once daily or a matching inactive placebo for 40 weeks, followed by a wash-out period of 6 weeks. Investigators, outcome assessors, data analysts and participants will all be blinded to the treatment allocation. The primary endpoint is improved arterial stiffness, as measured by carotid-femoral pulse wave velocity between baseline and 40 weeks. The secondary endpoints are incidence of hyperkalaemia, change in estimated glomerular filtration rate, change in urine albumin:creatinine ratio, change in brachial blood pressure, change in pulse waveform characteristics and overall tolerability of spironolactone. An additional quality control study, aiming to compare the laboratory serum potassium results of samples processed via two methods (utilizing routine transport or centrifugation on site before rapid transport to the laboratory) for 100 participants and a qualitative research study exploring patients’ and general practitioners’ attitudes to research and the use of spironolactone in chronic kidney disease in the community setting will be embedded in this pilot study. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80658312. |
format | Online Article Text |
id | pubmed-4113230 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-41132302014-07-29 Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial Ng, Khai P Jain, Poorva Heer, Gurdip Redman, Val Chagoury, Odette L Dowswell, George Greenfield, Sheila Freemantle, Nick Townend, Jonathan N Gill, Paramjit S McManus, Richard J Ferro, Charles J Trials Study Protocol BACKGROUND: Chronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition. The use of low-dose spironolactone has previously been shown to improve arterial stiffness and reduce left ventricular mass safely in early-stage chronic kidney disease in the context of careful monitoring at a university hospital. However, the majority of patients with chronic kidney disease are managed by their general practitioners in the community. It is not known whether similar beneficial effects can be achieved safely using spironolactone in the primary care setting. The aim of this study is to determine whether low-dose spironolactone can safely lower arterial stiffness in patients with stage 3 chronic kidney disease in the primary care setting. METHODS/DESIGN: STOP-CKD is a multicentre, prospective, randomized, double-blind, placebo-controlled pilot trial of 240 adult patients with stage 3 chronic kidney disease recruited from up to 20 general practices in South Birmingham, England. Participants will be randomly allocated using a secured web-based computer randomization system to receive either spironolactone 25 mg once daily or a matching inactive placebo for 40 weeks, followed by a wash-out period of 6 weeks. Investigators, outcome assessors, data analysts and participants will all be blinded to the treatment allocation. The primary endpoint is improved arterial stiffness, as measured by carotid-femoral pulse wave velocity between baseline and 40 weeks. The secondary endpoints are incidence of hyperkalaemia, change in estimated glomerular filtration rate, change in urine albumin:creatinine ratio, change in brachial blood pressure, change in pulse waveform characteristics and overall tolerability of spironolactone. An additional quality control study, aiming to compare the laboratory serum potassium results of samples processed via two methods (utilizing routine transport or centrifugation on site before rapid transport to the laboratory) for 100 participants and a qualitative research study exploring patients’ and general practitioners’ attitudes to research and the use of spironolactone in chronic kidney disease in the community setting will be embedded in this pilot study. TRIAL REGISTRATION: Current Controlled Trials ISRCTN80658312. BioMed Central 2014-05-06 /pmc/articles/PMC4113230/ /pubmed/24886272 http://dx.doi.org/10.1186/1745-6215-15-158 Text en Copyright © 2014 Ng et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), 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. |
spellingShingle | Study Protocol Ng, Khai P Jain, Poorva Heer, Gurdip Redman, Val Chagoury, Odette L Dowswell, George Greenfield, Sheila Freemantle, Nick Townend, Jonathan N Gill, Paramjit S McManus, Richard J Ferro, Charles J Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial |
title | Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial |
title_full | Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial |
title_fullStr | Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial |
title_full_unstemmed | Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial |
title_short | Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial |
title_sort | spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (stop-ckd): study protocol for a randomized controlled pilot trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4113230/ https://www.ncbi.nlm.nih.gov/pubmed/24886272 http://dx.doi.org/10.1186/1745-6215-15-158 |
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