{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T03:37:19Z","timestamp":1772163439436,"version":"3.50.1"},"reference-count":56,"publisher":"BMJ","issue":"2","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2016,2,1]]},"published-print":{"date-parts":[[2016,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To determine whether low-dose spironolactone can safely lower arterial stiffness in patients with chronic kidney disease stage 3 in the primary care setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A multicentre, prospective, randomised, placebo-controlled, double-blinded study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>11 primary care centres in South Birmingham, England.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Adult patients with stage 3 chronic kidney disease. Main exclusion criteria were diagnosis of diabetes mellitus, chronic heart failure, atrial fibrillation, severe hypertension, systolic blood pressure &lt;120\u2005mm\u2005Hg or baseline serum potassium \u22655\u2005mmol\/L.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Eligible participants were randomised to receive either spironolactone 25\u2005mg once daily, or matching placebo for an intended period of 40\u2005weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome measures<\/jats:title>\n                    <jats:p>The primary end point was the change in arterial stiffness as measured by pulse wave velocity. Secondary outcome measures included the rate of hyperkalaemia, deterioration of renal function, barriers to participation and expected recruitment rates to a potential future hard end point study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      From the 11 practices serving a population of 112\u2005462, there were 1598 (1.4%) patients identified as being eligible and were invited to participate. Of these, 134 (8.4%) attended the screening visit of which only 16 (1.0%) were eligible for randomisation. The main reasons for exclusion were low systolic blood pressure (&lt;120\u2005mm\u2005Hg: 40 patients) and high estimated glomerular filtration rate (\u226560\u2005mL\/min\/1.73\u2005m\n                      <jats:sup>2<\/jats:sup>\n                      : 38 patients). The trial was considered unfeasible and was terminated early.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We highlight some of the challenges in undertaking research in primary care including patient participation in trials. This study not only challenged our preconceptions, but also provided important learning for future research in this large and important group of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ISRCTN80658312.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2015-010519","type":"journal-article","created":{"date-parts":[[2016,2,25]],"date-time":"2016-02-25T22:19:04Z","timestamp":1456438744000},"page":"e010519","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":17,"title":["Results and lessons from the Spironolactone To Prevent Cardiovascular Events in Early Stage Chronic Kidney Disease (STOP-CKD) randomised controlled trial"],"prefix":"10.1136","volume":"6","clinical-trial-number":[{"clinical-trial-number":"isrctn80658312","registry":"10.18810\/isrctn"}],"author":[{"given":"Khai P","family":"Ng","sequence":"first","affiliation":[{"name":"Department of Renal Medicine, Queen Elizabeth Hospital Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Poorva","family":"Jain","sequence":"additional","affiliation":[{"name":"Department of Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paramjit S","family":"Gill","sequence":"additional","affiliation":[{"name":"Department of Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gurdip","family":"Heer","sequence":"additional","affiliation":[{"name":"Department of Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan N","family":"Townend","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Queen Elizabeth Hospital Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick","family":"Freemantle","sequence":"additional","affiliation":[{"name":"Department of Primary Care and Population Health, UCL Medical School, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sheila","family":"Greenfield","sequence":"additional","affiliation":[{"name":"Department of Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3638-028X","authenticated-orcid":false,"given":"Richard J","family":"McManus","sequence":"additional","affiliation":[{"name":"Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles J","family":"Ferro","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine, Queen Elizabeth Hospital Birmingham, Birmingham, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2016,2,25]]},"reference":[{"key":"2025121401030482000_6.2.e010519.1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa041031"},{"key":"2025121401030482000_6.2.e010519.2","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2005101085"},{"key":"2025121401030482000_6.2.e010519.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60674-5"},{"key":"2025121401030482000_6.2.e010519.4","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0025920"},{"key":"2025121401030482000_6.2.e010519.5","doi-asserted-by":"publisher","DOI":"10.1053\/ajkd.2002.32799"},{"key":"2025121401030482000_6.2.e010519.6","doi-asserted-by":"publisher","DOI":"10.1001\/jama.298.17.2038"},{"key":"2025121401030482000_6.2.e010519.7","doi-asserted-by":"publisher","DOI":"10.1136\/hrt.2009.184879"},{"key":"2025121401030482000_6.2.e010519.8","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2012-302818"},{"key":"2025121401030482000_6.2.e010519.9","doi-asserted-by":"publisher","DOI":"10.1097\/MNH.0b013e32830dcd5c"},{"key":"2025121401030482000_6.2.e010519.10","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.99.18.2434"},{"key":"2025121401030482000_6.2.e010519.11","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2004.11.011"},{"key":"2025121401030482000_6.2.e010519.12","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523-1755.2001.0590051834.x"},{"key":"2025121401030482000_6.2.e010519.13","doi-asserted-by":"publisher","DOI":"10.1097\/01.ASN.0000130566.69170.5E"},{"key":"2025121401030482000_6.2.e010519.14","doi-asserted-by":"publisher","DOI":"10.1136\/hrt.2007.137539"},{"key":"2025121401030482000_6.2.e010519.15","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2008.01.031"},{"key":"2025121401030482000_6.2.e010519.16","doi-asserted-by":"publisher","DOI":"10.1161\/01.ATV.0000160548.78317.29"},{"key":"2025121401030482000_6.2.e010519.17","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2010.07.018"},{"key":"2025121401030482000_6.2.e010519.18","doi-asserted-by":"publisher","DOI":"10.3122\/jabfm.2010.04.090129"},{"key":"2025121401030482000_6.2.e010519.19","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfm857"},{"key":"2025121401030482000_6.2.e010519.20","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2012.65"},{"key":"2025121401030482000_6.2.e010519.21","first-page":"419","article-title":"Ageing and the glomerular filtration rate: truths and consequences","volume":"120","author":"Glassock","year":"2009","journal-title":"Trans Am Clin Climatol Assoc"},{"key":"2025121401030482000_6.2.e010519.22","doi-asserted-by":"crossref","first-page":"158","DOI":"10.1186\/1745-6215-15-158","article-title":"Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial","volume":"15","author":"Ng","year":"2014","journal-title":"Trials"},{"key":"2025121401030482000_6.2.e010519.23","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2009020171"},{"key":"2025121401030482000_6.2.e010519.24","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-130-6-199903160-00002"},{"key":"2025121401030482000_6.2.e010519.25","unstructured":"National Institute for Health and Care Excellence. Chronic kidney disease: early identification and management of chronic kidney disease in adults in primary and secondary care (CG182). London: National Institute for Health and Care Excellence, 2014."},{"key":"2025121401030482000_6.2.e010519.26","unstructured":"National Institute for Health & Clinical Excellence. Hypertension: clinical management for primary hypertension in adults [CG127]. London: National Institute for Health & Clinical Excellence, 2011."},{"key":"2025121401030482000_6.2.e010519.27","doi-asserted-by":"publisher","DOI":"10.1177\/1470320315575849"},{"key":"2025121401030482000_6.2.e010519.28","doi-asserted-by":"publisher","DOI":"10.1038\/hr.2009.154"},{"key":"2025121401030482000_6.2.e010519.29","doi-asserted-by":"publisher","DOI":"10.1097\/00126097-200106000-00008"},{"key":"2025121401030482000_6.2.e010519.30","doi-asserted-by":"publisher","DOI":"10.1093\/fampra\/cmq067"},{"key":"2025121401030482000_6.2.e010519.31","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2009.03.066"},{"key":"2025121401030482000_6.2.e010519.32","doi-asserted-by":"crossref","first-page":"593","DOI":"10.1097\/MNH.0b013e328365adf6","article-title":"Chronic kidney disease in general populations and primary care: diagnostic and therapeutic considerations","volume":"22","author":"Taal","year":"2013","journal-title":"Curr Opin Nephrol Hypertens"},{"key":"2025121401030482000_6.2.e010519.33","doi-asserted-by":"publisher","DOI":"10.1186\/1745-6215-14-426"},{"key":"2025121401030482000_6.2.e010519.34","doi-asserted-by":"crossref","first-page":"e100831","DOI":"10.1371\/journal.pone.0100831","article-title":"The need for improved identification and accurate classification of stages 3\u20135 chronic kidney disease in primary care: retrospective cohort study","volume":"9","author":"Jain","year":"2014","journal-title":"PLoS ONE"},{"key":"2025121401030482000_6.2.e010519.35","unstructured":"Health and Social Care Information Centre. Quality and Outcomes Framework (QOF)\u20142013\u201314. 2014. http:\/\/www.hscic.gov.uk\/catalogue\/PUB15751"},{"key":"2025121401030482000_6.2.e010519.36","doi-asserted-by":"crossref","first-page":"1110","DOI":"10.1111\/ijcp.12454","article-title":"Prevalence and management of chronic kidney disease in primary care patients in the UK","volume":"68","author":"Jameson","year":"2014","journal-title":"Int J Clin Pract"},{"key":"2025121401030482000_6.2.e010519.37","unstructured":"Health and Social Care Information Centre. Quality And Outcomes Framework, Achievement, Prevalence And Exceptions Data, 2011\/12. 2012. http:\/\/www.hscic.gov.uk\/catalogue\/PUB08135\/qof-11-12-rep.pdf"},{"key":"2025121401030482000_6.2.e010519.38","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ki.5002273"},{"key":"2025121401030482000_6.2.e010519.39","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60033-6"},{"key":"2025121401030482000_6.2.e010519.40","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfn086"},{"key":"2025121401030482000_6.2.e010519.41","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-123-10-199511150-00003"},{"key":"2025121401030482000_6.2.e010519.42","doi-asserted-by":"publisher","DOI":"10.1503\/cmaj.121468"},{"key":"2025121401030482000_6.2.e010519.43","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-159-4-201308200-00004"},{"key":"2025121401030482000_6.2.e010519.44","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-11-201306040-00007"},{"key":"2025121401030482000_6.2.e010519.45","unstructured":"National Institutes of Health. Landmark NIH study shows intensive blood pressure management may save live. 11 September 2015. http:\/\/www.nhlbi.nih.gov\/news\/press-releases\/2015\/landmark-nih-study-shows-intensive-blood-pressure-management-may-save-lives"},{"key":"2025121401030482000_6.2.e010519.46","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1186\/1745-6215-15-160","article-title":"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","volume":"15","author":"Hill","year":"2014","journal-title":"Trials"},{"key":"2025121401030482000_6.2.e010519.47","unstructured":"Royal College of General Practitioners. Research Ready self accreditation. http:\/\/www.rcgp.org.uk\/researchready"},{"key":"2025121401030482000_6.2.e010519.48","unstructured":"Royal College of General Practitioners. More than 1000 GP practices now \u2018Research Ready\u2019. 27 January 2014. http:\/\/www.rcgp.org.uk\/news\/2014\/january\/more-than-1000-gp-practices-now-research-ready.aspx"},{"key":"2025121401030482000_6.2.e010519.49","unstructured":"NorthWestEHealth. FARSITE. http:\/\/nweh.co.uk\/products\/farsite"},{"key":"2025121401030482000_6.2.e010519.50","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2014-205259"},{"key":"2025121401030482000_6.2.e010519.51","doi-asserted-by":"crossref","unstructured":"Treweek S , Pitkethly M , Cook J , et al . Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev 2010;(4):MR000013. doi:10.1002\/14651858.MR000013.pub5","DOI":"10.1002\/14651858.MR000013.pub4"},{"key":"2025121401030482000_6.2.e010519.52","doi-asserted-by":"crossref","first-page":"261","DOI":"10.1186\/s13063-015-0776-0","article-title":"Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform","volume":"16","author":"Treweek","year":"2015","journal-title":"Trials"},{"key":"2025121401030482000_6.2.e010519.53","doi-asserted-by":"crossref","first-page":"iii","DOI":"10.3310\/hta11480","article-title":"Recruitment to randomised trials: strategies for trial enrollment and participation study. The STEPS study","volume":"11","author":"Campbell","year":"2007","journal-title":"Health Technol Assess"},{"key":"2025121401030482000_6.2.e010519.54","doi-asserted-by":"publisher","DOI":"10.1136\/jme.2010.041871"},{"key":"2025121401030482000_6.2.e010519.55","doi-asserted-by":"publisher","DOI":"10.1053\/j.ackd.2010.03.002"},{"key":"2025121401030482000_6.2.e010519.56","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1000368"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2015-010519","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,14]],"date-time":"2025-12-14T09:03:17Z","timestamp":1765702997000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2015-010519"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,2]]},"references-count":56,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2016,2,25]]},"published-print":{"date-parts":[[2016,2]]}},"alternative-id":["10.1136\/bmjopen-2015-010519"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2015-010519","relation":{"has-review":[{"id-type":"doi","id":"10.3410\/f.726176475.793515401","asserted-by":"object"}]},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,2]]}}}