{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,13]],"date-time":"2026-06-13T06:48:10Z","timestamp":1781333290520,"version":"3.54.1"},"reference-count":30,"publisher":"BMJ","issue":"7","funder":[{"DOI":"10.13039\/501100000659","name":"Research Trainees Coordinating Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000659","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,6,24]]},"published-print":{"date-parts":[[2019,7]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>The study is a multicentre, phase-3 randomised trial. The 1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months, randomly assigned to undergo a transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up. The primary outcome measure is time to all-cause mortality or heart failure hospitalisation. Secondary outcomes include external validation of our risk stratification model to predict onset of heart failure and quality of life assessment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and Dissemination<\/jats:title><jats:p>The trial design and protocol have received national ethical approval (12\/YH\/0487). The results of this randomised trial will be published in international peer-reviewed journals, communicated to healthcare professionals and patient involvement groups and highlighted using social media campaigns.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"NCT01819662\" ext-link-type=\"clintrialgov\">NCT01819662<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2018-028613","type":"journal-article","created":{"date-parts":[[2019,7,18]],"date-time":"2019-07-18T11:06:07Z","timestamp":1563447967000},"page":"e028613","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":7,"title":["Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial"],"prefix":"10.1136","volume":"9","clinical-trial-number":[{"clinical-trial-number":"nct01819662","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8517-4621","authenticated-orcid":false,"given":"Maria F","family":"Paton","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Gierula","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haqeel A","family":"Jamil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith E","family":"Lowry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rowena","family":"Byrom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard G","family":"Gillott","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hemant","family":"Chumun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard M","family":"Cubbon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Cairns","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah D","family":"Stocken","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark T","family":"Kearney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Klaus K","family":"Witte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,7,17]]},"reference":[{"key":"2024052012534855000_9.7.e028613.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2012.11.007"},{"key":"2024052012534855000_9.7.e028613.2","doi-asserted-by":"publisher","DOI":"10.1136\/hrt.53.6.587"},{"key":"2024052012534855000_9.7.e028613.3","doi-asserted-by":"crossref","first-page":"1097","DOI":"10.1056\/NEJM199804163381602","article-title":"Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing","volume":"338","author":"Lamas","year":"1998","journal-title":"N Engl J Med Overseas Ed"},{"key":"2024052012534855000_9.7.e028613.4","doi-asserted-by":"publisher","DOI":"10.1016\/0735-1097(94)90567-3"},{"key":"2024052012534855000_9.7.e028613.5","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2011-300198.154"},{"key":"2024052012534855000_9.7.e028613.6","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000072769.17295.B1"},{"key":"2024052012534855000_9.7.e028613.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0195-668X(03)00199-4"},{"key":"2024052012534855000_9.7.e028613.8","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8167.2007.01014.x"},{"key":"2024052012534855000_9.7.e028613.9","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2013-304905"},{"key":"2024052012534855000_9.7.e028613.10","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehl193"},{"key":"2024052012534855000_9.7.e028613.11","doi-asserted-by":"crossref","first-page":"743","DOI":"10.2459\/JCM.0000000000000117","article-title":"Patients with long-term permanent pacemakers have a high prevalence of left ventricular dysfunction","volume":"16","author":"Gierula","year":"2015","journal-title":"J Cardiovasc Med"},{"key":"2024052012534855000_9.7.e028613.12","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9149(94)90744-7"},{"key":"2024052012534855000_9.7.e028613.13","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8159.1992.tb03057.x"},{"key":"2024052012534855000_9.7.e028613.14","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8159.1999.tb00468.x"},{"key":"2024052012534855000_9.7.e028613.15","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8167.2008.01209.x"},{"key":"2024052012534855000_9.7.e028613.16","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-125-6-199609150-00008"},{"key":"2024052012534855000_9.7.e028613.17","doi-asserted-by":"publisher","DOI":"10.1016\/j.ehj.2003.10.022"},{"key":"2024052012534855000_9.7.e028613.18","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(99)00005-4"},{"key":"2024052012534855000_9.7.e028613.19","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/eur081"},{"key":"2024052012534855000_9.7.e028613.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.puhe.2008.11.001"},{"key":"2024052012534855000_9.7.e028613.21","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8159.2011.03075.x"},{"key":"2024052012534855000_9.7.e028613.22","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa071880"},{"key":"2024052012534855000_9.7.e028613.23","doi-asserted-by":"publisher","DOI":"10.1111\/j.1540-8159.2011.03314.x"},{"key":"2024052012534855000_9.7.e028613.24","doi-asserted-by":"publisher","DOI":"10.1093\/europace\/eus020"},{"key":"2024052012534855000_9.7.e028613.25","doi-asserted-by":"publisher","DOI":"10.1016\/j.echo.2014.10.003"},{"key":"2024052012534855000_9.7.e028613.26","unstructured":"Excellence, N.I.f.H.a.C. Dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome without atrioventricular block (TA324). London: NICE, 2014."},{"key":"2024052012534855000_9.7.e028613.27","unstructured":"NICE. Dual-chamber pacemakers for symptomatic bradycardia due to sick sinus syndrome and\/or atrioventricular block. 2017."},{"key":"2024052012534855000_9.7.e028613.28","unstructured":"Excellence, N.I.f.H.a.C. Chronic heart failure in adults: management. London: NICE, 2010."},{"key":"2024052012534855000_9.7.e028613.29","unstructured":"Higgins JPT , Green S . Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions. Oxford: Cochrane Collaboration, 2011."},{"key":"2024052012534855000_9.7.e028613.30","unstructured":"International Committee of Medical Journal Editors. Defining the role of authors and contributors. 2018 http:\/\/www.icmje.org\/recommendations\/browse\/roles-and-responsibilities\/defining-the-role-of-authors-and-contributors.html (Cited 01 Feb 2018)."}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2018-028613","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,20]],"date-time":"2024-05-20T20:06:15Z","timestamp":1716235575000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2018-028613"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,7]]},"references-count":30,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2019,7,17]]},"published-print":{"date-parts":[[2019,7]]}},"alternative-id":["10.1136\/bmjopen-2018-028613"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2018-028613","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,7]]}}}