Clinical trial NCT05017753: Thoracentesis to Alleviate Cardiac Pleural Effusion
Official title: Thoracentesis to Alleviate Cardiac Pleural Effusion - an Interventional Trial (TAP-IT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Pleural Effusion
Keywords: Heart failure
Systolic heart failure
Pleural effusion
Thoracentesis
Thoracocentesis
Pleurocentesis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Independent Research Fund Denmark
name: Hartmann Fonden
name: University Hospital Bispebjerg and Frederiksberg
First posted: 2021-08-24
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Days alive outside of hospital (days)
timeFrame: 90 days
Secondary outcomes:
measure: Satisfaction with hospital stay (Likert scale)
timeFrame: Up til 1 week after discharge
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-23) (score)
timeFrame: At 14 days and 90 days - up til 1 week
measure: Complications during hospital stay (count)
timeFrame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
measure: Complications to thoracentesis (count)
timeFrame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
measure: Duration of index admission (days)
timeFrame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
measure: Changes from baseline in weight during admission (kg)
timeFrame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
measure: Change from baseline in dosage of diuretics during admission (mg/day)
timeFrame: From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
measure: Time to death (days)
timeFrame: 90 days
measure: Time to first readmission or death (days)
timeFrame: 90 days
measure: Days alive and not hospitalized due to heart failure during the 90 days following randomization.
timeFrame: 90 days
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: University Hospital Aalborg
city: Aarhus
country: Denmark
facility: University Hospital Aarhus
city: Copenhagen
country: Denmark
facility: University Hospital Bispebjerg and Frederiksberg
city: Copenhagen
country: Denmark
facility: University Hospital Rigshospitalet
city: Glostrup
country: Denmark
facility: University Hospital Rigshospitalet, Glostrup
city: Herlev
country: Denmark
facility: University Hospital Herlev/Gentofte
city: Hillerød
country: Denmark
facility: University Hospital Nordsjaelland
city: Hvidovre
country: Denmark
facility: University Hospital Hvidovre
city: Odense
country: Denmark
facility: University Hospital Odense
city: Roskilde
country: Denmark
facility: University Hospital Zealand, Roskilde
Study officials:
References: