Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
135 participants
INTERVENTIONAL
2021-08-31
2024-12-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Study hypothesis: A strategy of referring patients with heart failure-related pleural effusion to thoracentesis increases number of days alive outside of hospital over the following 90 days.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Hypothesis: A strategy of referring patients with heart failure-related pleural effusion to thoracentesis increases number of days alive outside of hospital over the following 90 days.
Study Setting:126 adult patients admitted with systolic heart failure and pleural effusion documented by either chest x- ray, ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI) will be randomized 1:1 to medical treatment only or medical treatment and referral to thoracentesis. Thoracentesis will be performed according to local practice. Randomization will be stratified according to whether patients are treated with oral anticoagulation.
Crossover/rescue thoracentesis: For patients in the medical treatment arm whose condition deteriorates to the degree that the participant fulfill any of the study exclusion criteria (eg. increased need of oxygen), thoracentesis may be performed immediately. Some patients randomized to medical treatment only may prove to be too diuretic resistant to achieve an adequate effect of medical treatment alone. The recommended waiting period before performing thoracentesis on a patient in the control group is 5 days from randomization.
Patients may be discharged at the discretion of the treating physician. The follow up period is planned to 90 days.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
Standard-of-care medical treatment.
Standard-of-care medical treatment
Standard-of-care medical treatment
Intervention group
Thoracentesis in addition to standard-of-care medical treatment.
Thoracentesis
Thoracentesis will be performed according to local practice, either at the ward or at the radiology department, in addition to standard-of-care medical treatment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thoracentesis
Thoracentesis will be performed according to local practice, either at the ward or at the radiology department, in addition to standard-of-care medical treatment.
Standard-of-care medical treatment
Standard-of-care medical treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Non- negligible pleural effusion by x-ray, ultrasound, CT or MRI, suspected to be due to heart failure
* Age ≥ 18 years
Exclusion Criteria
* Suspected pulmonary or pleural infection (pneumonia symptoms with c- reactive protein\>100 mg/L or white blood count\>11)
* Recent (\<3 months) intrathoracic procedure (including heart or lung surgery, transcatheter aortic valve implantation (TAVI) or thoracentesis)
* Contraindications to thoracentesis according to local guidelines (such as spontaneously elevated international normalized ratio (INR) or thrombocytopenia), patients on oral anticoagulation may be randomized.
* Severe aortic stenosis
* Massive pleural effusion (equivalent to \>2/3 of lung on a standing chest x-ray)
* Substantially affected hemodynamics (systolic blood pressure \< 85mmHg, need of inotropes) or high oxygen demand (\>7L/min)
* Estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2 or dialysis treatment
* Planned or expected admission \> 10 days for other condition than heart failure
* Inability to give informed consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Independent Research Fund Denmark
INDUSTRY
Hartmann Fonden
OTHER
University Hospital Bispebjerg and Frederiksberg
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jens Jakob Thune
Clinical Research Associate Professor, Consultant Cardiologist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Aalborg
Aalborg, , Denmark
University Hospital Aarhus
Aarhus, , Denmark
University Hospital Bispebjerg and Frederiksberg
Copenhagen, , Denmark
University Hospital Rigshospitalet
Copenhagen, , Denmark
University Hospital Rigshospitalet, Glostrup
Glostrup Municipality, , Denmark
University Hospital Herlev/Gentofte
Herlev, , Denmark
University Hospital Nordsjaelland
Hillerød, , Denmark
University Hospital Hvidovre
Hvidovre, , Denmark
University Hospital Odense
Odense, , Denmark
University Hospital Zealand, Roskilde
Roskilde, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Glargaard S, Thomsen JH, Tuxen C, Lindholm MG, Bang CA, Schou M, Iversen K, Rasmussen RV, Logstrup BB, Vraa S, Stride N, Seven E, Barasa A, Tofterup M, Hofsten DE, Rossing K, Kober L, Gustafsson F, Thune JJ. A Randomized Controlled Trial of Thoracentesis in Acute Heart Failure. Circulation. 2025 Apr 22;151(16):1150-1161. doi: 10.1161/CIRCULATIONAHA.124.073521. Epub 2025 Apr 1.
Glargaard S, Thomsen JH, Logstrup BB, Schou M, Iversen KK, Tuxen C, Nielsen OW, Bang CA, Lindholm MG, Seven E, Barasa A, Stride N, Vraa S, Tofterup M, Rasmussen RV, Hofsten DE, Rossing K, Kober L, Gustafsson F, Thune JJ. Thoracentesis to alleviate pleural effusion in acute heart failure: study protocol for the multicentre, open-label, randomised controlled TAP-IT trial. BMJ Open. 2024 Jan 19;14(1):e078155. doi: 10.1136/bmjopen-2023-078155.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TAP-IT
Identifier Type: -
Identifier Source: org_study_id