An interventional study of Thoracentesis and Standard-of-care medical treatment in Heart Failure and Pleural Effusion, sponsored by Bispebjerg Hospital. Completed at 10 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment
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.
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.
5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 135 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Standard-of-care medical treatment.
Drug: Standard-of-care medical treatment
Thoracentesis in addition to standard-of-care medical treatment.
Procedure: 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.
Also known as: Thoracocentesis, Pleurocentesis
Standard-of-care medical treatment
Days alive outside of hospital (days)
Number of days the patient is alive outside of hospital in the 90 days following randomization
Time frame: 90 days
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.
Time frame: 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.
Time frame: 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)
Time frame: 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
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)
Duration of index admission following randomization.
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)
Changes in weight during admission
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)
Change in dosage of diuretics during index admission
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
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data necessary to reproduce published results will be made available on reasonable requests.
Ran from Aug 2021 to primary completion in Mar 2024, 30 months.
Of 1,018 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 30 months is close to that.
Counting every sponsor, half of 1,220 studies reached it within 31 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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