{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T18:41:49Z","timestamp":1775155309555,"version":"3.50.1"},"reference-count":36,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2024,1,20]],"date-time":"2024-01-20T00:00:00Z","timestamp":1705708800000},"content-version":"unspecified","delay-in-days":19,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Per Henriksen's Fund","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"The Independent Research Fund Denmark","award":["1030-00121B"],"award-info":[{"award-number":["1030-00121B"]}]},{"name":"Research Foundation at Copenhagen University Hospital - Bispebjerg and Frederiksberg","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"DOI":"10.13039\/501100009910","name":"Hartmann Foundation","doi-asserted-by":"crossref","award":["A36846"],"award-info":[{"award-number":["A36846"]}],"id":[{"id":"10.13039\/501100009910","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,12,21]]},"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Pleural effusion is present in half of the patients hospitalised with acute heart failure. The condition is treated with diuretics and\/or therapeutic thoracentesis for larger effusions. No evidence from randomised trials or guidelines supports thoracentesis to alleviate pleural effusion due to acute heart failure. The Thoracentesis to Alleviate cardiac Pleural effusion Interventional Trial (TAP-IT) will investigate if a strategy of referring patients with acute heart failure and pleural effusion to up-front thoracentesis by pleural pigtail catheter insertion in addition to pharmacological therapy compared with pharmacological therapy alone can increase the number of days the participants are alive and not hospitalised during the 90 days following randomisation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>TAP-IT is a pragmatic, multicentre, open-label, randomised controlled trial aiming to include 126 adult patients with left ventricular ejection fraction \u226445%\u2009and a non-negligible pleural effusion due to heart failure. Participants will be randomised 1:1, stratified according to site and anticoagulant treatment, and assigned to referral to up-front ultrasound-guided pleural pigtail catheter thoracentesis in addition to standard pharmacological therapy or to standard pharmacological therapy only. Thoracentesis is performed according to local guidelines and can be performed in participants in the pharmacological treatment arm if their condition deteriorates or if no significant improvement is observed within 5\u2009days. The primary endpoint is how many days participants are alive and not hospitalised within 90 days from randomisation and will be analysed in the intention-to-treat population. Key secondary outcomes include 90-day mortality, complications, readmissions, and quality of life.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The study has been approved by the Capital Region of Denmark Scientific Ethical Committee (H-20060817) and Knowledge Center for Data Reviews (P-2021\u2013149). All participants will sign an informed consent form. Enrolment began in August 2021. Regardless of the nature, results will be published in a peer-reviewed medical journal.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05017753\">NCT05017753<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-078155","type":"journal-article","created":{"date-parts":[[2024,1,20]],"date-time":"2024-01-20T01:10:23Z","timestamp":1705713023000},"page":"e078155","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05017753","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05017753","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7113-5055","authenticated-orcid":false,"given":"Signe","family":"Glargaard","sequence":"first","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jakob Hartvig","family":"Thomsen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian Bridal","family":"L\u00f8gstrup","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark"},{"name":"Department of Clinical Medicine, Aarhus University, Aarhus, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morten","family":"Schou","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Herlev and Gentofte, Herlev, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kasper Karmark","family":"Iversen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Herlev and Gentofte, Herlev, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Tuxen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olav W","family":"Nielsen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian Axel","family":"Bang","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matias Greve","family":"Lindholm","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Zealand University Hospital Roskilde, Roskilde, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ekim","family":"Seven","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Amager and Hvidovre, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anders","family":"Barasa","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Glostrup, Glostrup, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nis","family":"Stride","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014North Zealand, Hilleroed, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00f8ren","family":"Vraa","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marlene","family":"Tofterup","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rasmus Vedby","family":"Rasmussen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Herlev and Gentofte, Herlev, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dan Eik","family":"H\u00f8fsten","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kasper","family":"Rossing","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"K\u00f8ber","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Finn","family":"Gustafsson","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Cardiology, Heart Centre, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jens Jakob","family":"Thune","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Copenhagen University Hospital\u2014Bispebjerg and Frederiksberg, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,1,19]]},"reference":[{"key":"2025101811521543000_14.1.e078155.1","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1016\/j.ejim.2018.02.004","article-title":"Pleural effusions in acute decompensated heart failure: prevalence and prognostic implications","volume":"52","author":"Morales-Rull","year":"2018","journal-title":"Eur J Intern Med"},{"key":"2025101811521543000_14.1.e078155.2","first-page":"513","article-title":"Quantification of pleural effusions on thoracic ultrasound in acute heart failure","volume":"9","author":"Lindner","year":"2020","journal-title":"Eur Heart J Acute Cardiovasc Care"},{"key":"2025101811521543000_14.1.e078155.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2021.12.011"},{"key":"2025101811521543000_14.1.e078155.4","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehab368"},{"key":"2025101811521543000_14.1.e078155.5","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1016\/S2213-2600(19)30373-X","article-title":"Malignant pleural effusion management: keeping the flood gates shut","volume":"8","author":"Walker","year":"2020","journal-title":"Lancet Respir Med"},{"key":"2025101811521543000_14.1.e078155.6","first-page":"ii41","article-title":"Management of pleural infection in adults: British Thoracic Society pleural disease guideline 2010","volume":"65 Suppl 2","author":"Davies","year":"2010","journal-title":"Thorax"},{"key":"2025101811521543000_14.1.e078155.7","doi-asserted-by":"crossref","first-page":"2422","DOI":"10.1001\/jama.2014.5552","article-title":"Does this patient have an exudative pleural effusion","volume":"311","author":"Wilcox","year":"2014","journal-title":"JAMA"},{"key":"2025101811521543000_14.1.e078155.8","doi-asserted-by":"crossref","first-page":"378","DOI":"10.1097\/MCP.0000000000000285","article-title":"Complications of thoracentesis: incidence, risk factors, and strategies for prevention","volume":"22","author":"Cantey","year":"2016","journal-title":"Curr Opin Pulm Med"},{"key":"2025101811521543000_14.1.e078155.9","doi-asserted-by":"crossref","first-page":"1099","DOI":"10.1016\/j.chest.2016.12.014","article-title":"Nonmalignant pleural effusions: a prospective study of 356 consecutive unselected patients","volume":"151","author":"Walker","year":"2017","journal-title":"Chest"},{"key":"2025101811521543000_14.1.e078155.10","doi-asserted-by":"crossref","DOI":"10.1177\/2373997515600404","article-title":"Patient-centered outcomes following thoracentesis","volume":"2","author":"Argento","year":"2015","journal-title":"PLEURA (Thousand Oaks)"},{"key":"2025101811521543000_14.1.e078155.11","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1080\/00015385.2019.1591677","article-title":"Lung ultrasound-guided therapeutic thoracentesis in refractory congestive heart failure","volume":"75","author":"Lazarevic","year":"2020","journal-title":"Acta Cardiol"},{"key":"2025101811521543000_14.1.e078155.12","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.111.963413"},{"key":"2025101811521543000_14.1.e078155.13","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.112.000265"},{"key":"2025101811521543000_14.1.e078155.14","doi-asserted-by":"crossref","first-page":"1863","DOI":"10.1016\/j.amjcard.2020.03.032","article-title":"Outcomes of thoracentesis for acute heart failure in hospitals","volume":"125","author":"Shetty","year":"2020","journal-title":"Am J Cardiol"},{"key":"2025101811521543000_14.1.e078155.15","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00217114"},{"key":"2025101811521543000_14.1.e078155.16","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2012.09.128"},{"key":"2025101811521543000_14.1.e078155.17","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehl407"},{"key":"2025101811521543000_14.1.e078155.18","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMcp010731"},{"key":"2025101811521543000_14.1.e078155.19","doi-asserted-by":"publisher","DOI":"10.1055\/s-0030-1269828"},{"key":"2025101811521543000_14.1.e078155.20","unstructured":"Porcel JM , Light RW . Effusions from cardiovascular diseases. In: Light RW , Lee YCG , eds. Textbook of pleural diseases. Boca Raton: CRC Press, 2016: 269\u201377."},{"key":"2025101811521543000_14.1.e078155.21","doi-asserted-by":"crossref","first-page":"629","DOI":"10.1016\/j.arbres.2017.04.018","article-title":"Diagnosis and management of pleural transudates","volume":"53","author":"Ferreiro","year":"2017","journal-title":"Arch Bronconeumol"},{"key":"2025101811521543000_14.1.e078155.22","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehz641"},{"key":"2025101811521543000_14.1.e078155.23","first-page":"ii4","article-title":"Investigation of a unilateral pleural effusion in adults: British Thoracic Society pleural disease guideline 2010","volume":"65 Suppl 2","author":"Hooper","year":"2010","journal-title":"Thorax"},{"key":"2025101811521543000_14.1.e078155.24","doi-asserted-by":"crossref","first-page":"336","DOI":"10.1097\/RTI.0000000000000147","article-title":"Estimation of pleural fluid volumes on chest radiography using computed tomography volumetric analysis: an update of the visual prediction rule","volume":"30","author":"Mammarappallil","year":"2015","journal-title":"J Thorac Imaging"},{"key":"2025101811521543000_14.1.e078155.25","doi-asserted-by":"publisher","DOI":"10.1148\/radiology.191.3.8184046"},{"key":"2025101811521543000_14.1.e078155.26","doi-asserted-by":"publisher","DOI":"10.1002\/ejhf.1369"},{"key":"2025101811521543000_14.1.e078155.27","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2020.09.542"},{"key":"2025101811521543000_14.1.e078155.28","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(00)00531-3"},{"key":"2025101811521543000_14.1.e078155.29","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2017.12.048"},{"key":"2025101811521543000_14.1.e078155.30","doi-asserted-by":"crossref","first-page":"1469","DOI":"10.1001\/jamainternmed.2019.2431","article-title":"Perioperative management of patients with atrial fibrillation receiving a direct oral anticoagulant","volume":"179","author":"Douketis","year":"2019","journal-title":"JAMA Intern Med"},{"key":"2025101811521543000_14.1.e078155.31","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehl193"},{"key":"2025101811521543000_14.1.e078155.32","first-page":"464","article-title":"Precipitating clinical factors, heart failure characterization, and outcomes in patients hospitalized with heart failure with reduced, borderline, and preserved ejection fraction","volume":"4","author":"Kapoor","year":"2016","journal-title":"JACC: Heart Failure"},{"key":"2025101811521543000_14.1.e078155.33","doi-asserted-by":"crossref","first-page":"902","DOI":"10.1164\/rccm.202104-1063PP","article-title":"Hospital-free days: a pragmatic and patient-centered outcome for trials among critically and seriously ill patients","volume":"204","author":"Auriemma","year":"2021","journal-title":"Am J Respir Crit Care Med"},{"key":"2025101811521543000_14.1.e078155.34","first-page":"227","article-title":"Count data analysis in randomised clinical trials","volume":"6","author":"Jakobsen","year":"2015","journal-title":"J Biom Biostat"},{"key":"2025101811521543000_14.1.e078155.35","doi-asserted-by":"crossref","first-page":"3991","DOI":"10.1002\/sim.7890","article-title":"Confidence intervals of the Mann-Whitney parameter that are compatible with the Wilcoxon-Mann-Whitney test","volume":"37","author":"Fay","year":"2018","journal-title":"Stat Med"},{"key":"2025101811521543000_14.1.e078155.36","doi-asserted-by":"crossref","first-page":"598","DOI":"10.22237\/jmasm\/1130804700","article-title":"Misconceptions leading to choosing the t test over the Wilcoxon Mann-Whitney test for shift in location parameter","volume":"4","author":"Sawilowsky","year":"2005","journal-title":"J Mod App Stat Meth"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-078155","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T18:52:25Z","timestamp":1760813545000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-078155"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":36,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,1,19]]},"published-print":{"date-parts":[[2024,1]]}},"alternative-id":["10.1136\/bmjopen-2023-078155"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-078155","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]}}}