Thoracentesis to Alleviate Cardiac Pleural Effusion (TAP-IT)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Pleural Effusion
• Intervention / Treatment: Drug: Standard-of-care medical treatment; Procedure: Thoracentesis

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • University Hospital Aalborg
  • Aarhus, Denmark
    • University Hospital Aarhus
  • Copenhagen, Denmark
    • University Hospital Bispebjerg and Frederiksberg
  • Copenhagen, Denmark
    • University Hospital Rigshospitalet
  • Glostrup, Denmark
    • University Hospital Rigshospitalet, Glostrup
  • Herlev, Denmark
    • University Hospital Herlev/Gentofte
  • Hillerød, Denmark
    • University Hospital Nordsjaelland
  • Hvidovre, Denmark
    • University Hospital Hvidovre
  • Odense, Denmark
    • University Hospital Odense
  • Roskilde, Denmark
    • University Hospital Zealand, Roskilde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Standard-of-care medical treatment.	Drug: Standard-of-care medical treatment; Standard-of-care medical treatment
Experimental: Intervention group; 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.; Other Names: Thoracocentesis; Pleurocentesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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.
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.
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.
Time to death (days)		90 days
Time to first readmission or death (days)		90 days
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
Days alive and not hospitalized due to heart failure during the 90 days following randomization.		90 days

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Collaborators: University Hospital Bispebjerg and Frederiksberg; Hartmann Fonden; Independent Research Fund Denmark

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Heart failure; Pleural effusion; Thoracentesis; Systolic heart failure; Thoracocentesis; Pleurocentesis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Respiratory Tract Diseases; Pleural Diseases; Heart Failure; Pleural Effusion
• Other Study ID Numbers: TAP-IT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data necessary to reproduce published results will be made available on reasonable requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No