Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial
Introduction 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...
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BMJ Publishing Group
2024-01-01
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| author | Lars Køber Morten Schou Kasper Karmark Iversen Dan Eik Høfsten Finn Gustafsson Brian Bridal Løgstrup Olav W Nielsen Kasper Rossing Signe Glargaard Jakob Hartvig Thomsen Christian Tuxen Christian Axel Bang Matias Greve Lindholm Ekim Seven Anders Barasa Nis Stride Søren Vraa Marlene Tofterup Rasmus Vedby Rasmussen Jens Jakob Thune |
| author_facet | Lars Køber Morten Schou Kasper Karmark Iversen Dan Eik Høfsten Finn Gustafsson Brian Bridal Løgstrup Olav W Nielsen Kasper Rossing Signe Glargaard Jakob Hartvig Thomsen Christian Tuxen Christian Axel Bang Matias Greve Lindholm Ekim Seven Anders Barasa Nis Stride Søren Vraa Marlene Tofterup Rasmus Vedby Rasmussen Jens Jakob Thune |
| author_sort | Lars Køber |
| collection | DOAJ |
| description | Introduction 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.Methods and analysis TAP-IT is a pragmatic, multicentre, open-label, randomised controlled trial aiming to include 126 adult patients with left ventricular ejection fraction ≤45% and 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 days. 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.Ethics and dissemination The study has been approved by the Capital Region of Denmark Scientific Ethical Committee (H-20060817) and Knowledge Center for Data Reviews (P-2021–149). 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.Trial registration number NCT05017753. |
| format | Article |
| id | doaj-art-3a0c7f501ed04e7796f4823d3efa653f |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-01-01 |
| publisher | BMJ Publishing Group |
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| spelling | doaj-art-3a0c7f501ed04e7796f4823d3efa653f2025-08-20T03:12:35ZengBMJ Publishing GroupBMJ Open2044-60552024-01-0114110.1136/bmjopen-2023-078155Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trialLars Køber0Morten Schou1Kasper Karmark Iversen2Dan Eik Høfsten3Finn Gustafsson4Brian Bridal Løgstrup5Olav W Nielsen6Kasper Rossing7Signe Glargaard8Jakob Hartvig Thomsen9Christian Tuxen10Christian Axel Bang11Matias Greve Lindholm12Ekim Seven13Anders Barasa14Nis Stride15Søren Vraa16Marlene Tofterup17Rasmus Vedby Rasmussen18Jens Jakob Thune19Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkDepartment of Cardiology, Herlev Hospital, Herlev, DenmarkDepartment of Cardiology, Copenhagen University Hospital—Herlev and Gentofte, Herlev, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Rigshospitalet, Kobenhavn, DenmarkDepartment of Cardiology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Cardiology, Copenhagen University Hospital—Bispebjerg and Frederiksberg, Copenhagen, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital—Bispebjerg and Frederiksberg, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital—Bispebjerg and Frederiksberg, Copenhagen, DenmarkDepartment of Cardiology, Copenhagen University Hospital—Bispebjerg and Frederiksberg, Copenhagen, DenmarkDepartment of Cardiology, Zealand University Hospital Roskilde, Roskilde, DenmarkDepartment of Cardiology, Zealand University Hospital Roskilde, Roskilde, DenmarkDepartment of Cardiology, Copenhagen University Hospital Hvidovre, Hvidovre, DenmarkDepartment of Cardiology, Copenhagen University Hospital—Glostrup, Glostrup, DenmarkDepartment of Cardiology, Copenhagen University Hospital—North Zealand, Hilleroed, DenmarkDepartment of Cardiology, Aalborg University Hospital, Aalborg, DenmarkDepartment of Cardiology, Odense University Hospital, Odense, DenmarkDepartment of Cardiology, Copenhagen University Hospital—Herlev and Gentofte, Herlev, DenmarkDepartment of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkIntroduction 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.Methods and analysis TAP-IT is a pragmatic, multicentre, open-label, randomised controlled trial aiming to include 126 adult patients with left ventricular ejection fraction ≤45% and 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 days. 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.Ethics and dissemination The study has been approved by the Capital Region of Denmark Scientific Ethical Committee (H-20060817) and Knowledge Center for Data Reviews (P-2021–149). 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.Trial registration number NCT05017753.https://bmjopen.bmj.com/content/14/1/e078155.full |
| spellingShingle | Lars Køber Morten Schou Kasper Karmark Iversen Dan Eik Høfsten Finn Gustafsson Brian Bridal Løgstrup Olav W Nielsen Kasper Rossing Signe Glargaard Jakob Hartvig Thomsen Christian Tuxen Christian Axel Bang Matias Greve Lindholm Ekim Seven Anders Barasa Nis Stride Søren Vraa Marlene Tofterup Rasmus Vedby Rasmussen Jens Jakob Thune Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial BMJ Open |
| title | Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial |
| title_full | Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial |
| title_fullStr | Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial |
| title_full_unstemmed | Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial |
| title_short | Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial |
| title_sort | thoracentesis to alleviate pleural effusion in acute heart failure study protocol for the multicentre open label randomised controlled tap it trial |
| url | https://bmjopen.bmj.com/content/14/1/e078155.full |
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