Thoracentesis to Alleviate Cardiac Pleural Effusion

Heart Failure Clinical Trial

— TAP-IT  

Official title:

Thoracentesis to Alleviate Cardiac Pleural Effusion - an Interventional Trial (TAP-IT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05017753
• Other study ID #: TAP-IT
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: Bispebjerg Hospital
• Contact: Signe Glargaard, MD
• Phone: 61696721
• Email: signe.glargaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Pleural Effusion

Intervention

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.

Drug:
• Standard-of-care medical treatment
Standard-of-care medical treatment

Locations

Country	Name	City	State
Denmark	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
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

Sponsors (4)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Hartmann Fonden, Independent Research Fund Denmark, University Hospital Bispebjerg and Frederiksberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive outside of hospital (days)	Number of days the patient is alive outside of hospital in the 90 days following randomization	90 days
Secondary	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.	Up til 1 week after discharge
Secondary	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.	At 14 days and 90 days - up til 1 week
Secondary	Complications during hospital stay (count)	Number of complications during the index admission (eg. infections, delirium, falls, thrombosis)	From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Secondary	Complications to thoracentesis (count)	Number of complications to interventional thoracentesis	From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Secondary	Duration of index admission (days)	Duration of index admission following randomization.	From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Secondary	Changes from baseline in weight during admission (kg)	Changes in weight during admission	From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Secondary	Change from baseline in dosage of diuretics during admission (mg/day)	Change in dosage of diuretics during index admission	From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.
Secondary	Time to death (days)		90 days
Secondary	Time to first readmission or death (days)		90 days
Secondary	Days alive and not hospitalized due to heart failure during the 90 days following randomization.		90 days