Heart FailureTAP-ITNCT05017753
Thoracentesis to Alleviate Cardiac Pleural Effusion
A study testing Thoracentesis and Standard-of-care medical treatment in people with Heart Failure and Pleural Effusion, run by Bispebjerg Hospital at 10 sites in Denmark.
Trial summary
The present study will examine the comparative effectiveness of two treatment strategies currently used in the treatment of patients with systolic heart failure presenting with pleural effusion. Patients will be randomized to standard medical treatment only or medical treatment and referral to thoracentesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Pleural Effusion
- What is being tested?
- Thoracentesis and Standard-of-care medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 10 sitesDenmark
- Study dates
- 31 Aug 2021to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular ejection fraction (LVEF) ≤ 45%
- Non- negligible pleural effusion by x-ray, ultrasound, CT or MRI, suspected to be due to heart failure
- Age ≥ 18 years
Who cannot join
- Clinically indicated diagnostic thoracentesis (e.g. suspected malignant aetiology)
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Denmark10 sites
University Hospital Aalborg
Aalborg
University Hospital Aarhus
Aarhus
University Hospital Bispebjerg and Frederiksberg
Copenhagen
University Hospital Rigshospitalet
Copenhagen
University Hospital Rigshospitalet, Glostrup
Glostrup Municipality
University Hospital Herlev/Gentofte
Herlev
University Hospital Nordsjaelland
Hillerød
University Hospital Hvidovre
Hvidovre
University Hospital Odense
Odense
University Hospital Zealand, Roskilde
Roskilde
About this study
Official title: Thoracentesis to Alleviate Cardiac Pleural Effusion - an Interventional Trial (TAP-IT)
The present study will examine the comparative effectiveness of two treatment strategies currently used in the treatment of patients with systolic heart failure presenting with pleural effusion. Patients will be randomized to standard medical treatment only or medical treatment and referral to thoracentesis.
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.
Read the detailed description
Purpose and Rationale: Pleural effusion is a common presentation in patients with heart failure, and the condition is related to a poor prognosis and increased mortality. Therapeutic options consist of intensification of diuretic treatment and invasive drainage of the effusion (thoracentesis). Thoracentesis is a common medical procedure and is often performed on patients with heart failure presenting with a pleural effusion, but there is no randomized evidence to guide the use of thoracentesis in heart failure-related pleural effusion. International guidelines provide no recommendations. Some Danish hospitals use thoracentesis frequently, some rarely. Hence, there is true clinical equipoise and a strong need to assess whether thoracentesis benefits patients or not.
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
- Heart Failure, Pleural Effusion
- Being tested
- Thoracentesis, Standard-of-care medical treatment
- Keywords
- Heart failure, Systolic heart failure, Pleural effusion, Thoracentesis, Thoracocentesis, Pleurocentesis
- Medical subject headings
- Heart Failure, Pleural Effusion, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracentesisProcedure or surgery
Also called Thoracocentesis, Pleurocentesis
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 treatmentDrug
Standard-of-care medical treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard-of-care medical treatment. Receives: Drug: Standard-of-care medical treatment |
| Intervention group | Experimental | Thoracentesis in addition to standard-of-care medical treatment. Receives: Procedure: Thoracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive outside of hospital (days)
Number of days the patient is alive outside of hospital in the 90 days following randomization
Measured: 90 days
Secondary outcomes (10)
Satisfaction with hospital stay (Likert scale)
Selected questions from the questionnaire "Questions about your admission" from the annual Danish National Survey of Patient Experiences to assess satisfaction with index admission. Likert scale from 1-5. 5 represents the best outcome.
Measured: Up til 1 week after discharge
Kansas City Cardiomyopathy Questionnaire (KCCQ-23) (score)
Kansas City Cardiomyopathy Questionnaire (KCCQ). Selected scores from the 23-item questionnaire at 14 and 90 days. Scores from 0-100 with 100 representing the best outcome.
Measured: At 14 days and 90 days - up til 1 week
Complications during hospital stay (count)
Number of complications during the index admission (eg. infections, delirium, falls, thrombosis)
Measured: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Complications to thoracentesis (count)
Number of complications to interventional thoracentesis
Measured: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Duration of index admission (days)
Duration of index admission following randomization.
Measured: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Changes from baseline in weight during admission (kg)
Changes in weight during admission
Measured: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Change from baseline in dosage of diuretics during admission (mg/day)
Change in dosage of diuretics during index admission
Measured: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Time to death (days)
Measured: 90 days
Time to first readmission or death (days)
Measured: 90 days
Days alive and not hospitalized due to heart failure during the 90 days following randomization.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start31 Aug 2021
- Primary completion22 Mar 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is a pragmatic controlled, randomized, multicenter open label trial with including patients admitted with pleural effusion related to systolic heart failure. Patients will be randomized 1:1 to standard-of-care medical treatment only or standard-of-care medical treatment and referral to thoracentesis. Randomization will be stratified according to whether patients are treated with oral anticoagulation.
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Independent Research Fund Denmark, Hartmann Fonden, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Jens Jakob Thune, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017753
- Sponsor's protocol ID
- TAP-IT
- Acronym
- TAP-IT
- Status last verified
- Dec 2024
- First submitted
- 12 Aug 2021
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data necessary to reproduce published results will be made available on reasonable requests.
Publications
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.
PubMed 40166829Glargaard 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.
PubMed 38245015
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracentesis to Alleviate Cardiac Pleural Effusion - an Interventional Trial (TAP-IT)
- ClinicalTrials.gov ID
- NCT05017753
- Acronym / sponsor ID
- TAP-IT / TAP-IT
- Conditions
- Heart Failure, Pleural Effusion
- Keywords
- Heart failure, Systolic heart failure, Pleural effusion, Thoracentesis, Thoracocentesis, Pleurocentesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Independent Research Fund Denmark, Hartmann Fonden, University Hospital Bispebjerg and Frederiksberg
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will examine the comparative effectiveness of two treatment strategies currently used in the treatment of patients with systolic heart failure presenting with pleural effusion. Patients will be randomized to standard medical treatment only or medical treatment and referral to thoracentesis.
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
Purpose and Rationale: Pleural effusion is a common presentation in patients with heart failure, and the condition is related to a poor prognosis and increased mortality. Therapeutic options consist of intensification of diuretic treatment and invasive drainage of the effusion (thoracentesis). Thoracentesis is a common medical procedure and is often performed on patients with heart failure presenting with a pleural effusion, but there is no randomized evidence to guide the use of thoracentesis in heart failure-related pleural effusion. International guidelines provide no recommendations. Some Danish hospitals use thoracentesis frequently, some rarely. Hence, there is true clinical equipoise and a strong need to assess whether thoracentesis benefits patients or not.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial is a pragmatic controlled, randomized, multicenter open label trial with including patients admitted with pleural effusion related to systolic heart failure. Patients will be randomized 1:1 to standard-of-care medical treatment only or standard-of-care medical treatment and referral to thoracentesis. Randomization will be stratified according to whether patients are treated with oral anticoagulation.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Standard-of-care medical treatmentStandard-of-care medical treatment. |
| Intervention group | Experimental | Procedure: ThoracentesisThoracentesis in addition to standard-of-care medical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Left ventricular ejection fraction (LVEF) ≤ 45%
- Non- negligible pleural effusion by x-ray, ultrasound, CT or MRI, suspected to be due to heart failure
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- Clinically indicated diagnostic thoracentesis (e.g. suspected malignant aetiology)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThoracentesisAlso: Thoracocentesis, PleurocentesisThoracentesis will be performed according to local practice, either at the ward or at the radiology department, in addition to standard-of-care medical treatment. | Procedure or surgery | Intervention group |
| Standard-of-care medical treatmentStandard-of-care medical treatment | Drug | Control group |
Primary outcome
Days alive outside of hospital (days)
Time frame: 90 days
Number of days the patient is alive outside of hospital in the 90 days following randomization
10 secondary outcomes
Satisfaction with hospital stay (Likert scale)
Time frame: Up til 1 week after discharge
Kansas City Cardiomyopathy Questionnaire (KCCQ-23) (score)
Time frame: At 14 days and 90 days - up til 1 week
Complications during hospital stay (count)
Time frame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Complications to thoracentesis (count)
Time frame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Duration of index admission (days)
Time frame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Changes from baseline in weight during admission (kg)
Time frame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Change from baseline in dosage of diuretics during admission (mg/day)
Time frame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Time to death (days)
Time frame: 90 days
Time to first readmission or death (days)
Time frame: 90 days
Days alive and not hospitalized due to heart failure during the 90 days following randomization.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Derived from this study: PubMed 40166829Glargaard 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.
- Derived from this study: PubMed 38245015Glargaard 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.
- Individual participant dataSharing planned: Yes. De-identified data necessary to reproduce published results will be made available on reasonable requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracentesis and Standard-of-care medical treatment in people with Heart Failure and Pleural Effusion, run by Bispebjerg Hospital at 10 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive outside of hospital (days) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05017753, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.