Thoracentesis to Alleviate Cardiac Pleural Effusion

NCT05017753 | Completed DMC

• 1 other identifier: TAP-IT
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 10

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.

Conditions

Heart Failure; Pleural Effusion

Keywords

Heart failure; Systolic heart failure; Pleural effusion; Thoracentesis; Thoracocentesis; Pleurocentesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Satisfaction with hospital stay (Likert scale)

  Up til 1 week after discharge

• Kansas City Cardiomyopathy Questionnaire (KCCQ-23) (score)

  At 14 days and 90 days - up til 1 week

• Complications during hospital stay (count)

  From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.

• Complications to thoracentesis (count)

  From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.

• Duration of index admission (days)

  From randomization until the date af discharge from hospital. Estimated time frame from 2 days to 3 weeks.

Study Arms (2)

Control group

ACTIVE COMPARATOR

Standard-of-care medical treatment.

Drug: Standard-of-care medical treatment

Intervention group

EXPERIMENTAL

Thoracentesis in addition to standard-of-care medical treatment.

Procedure: Thoracentesis

Interventions

Thoracentesis PROCEDURE

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

Intervention group

Standard-of-care medical treatment DRUG

Standard-of-care medical treatment

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Independent Research Fund Denmark: collaborator
• Hartmann Fonden: collaborator
• University Hospital Bispebjerg and Frederiksberg: collaborator

Study Sites (10)

University Hospital Aalborg

Aalborg, Denmark

Location

University Hospital Aarhus

Aarhus, Denmark

Location

University Hospital Bispebjerg and Frederiksberg

Copenhagen, Denmark

Location

University Hospital Rigshospitalet

Copenhagen, Denmark

Location

University Hospital Rigshospitalet, Glostrup

Glostrup Municipality, Denmark

Location

University Hospital Herlev/Gentofte

Herlev, Denmark

Location

University Hospital Nordsjaelland

Hillerød, Denmark

Location

University Hospital Hvidovre

Hvidovre, Denmark

Location

University Hospital Odense

Odense, Denmark

Location

University Hospital Zealand, Roskilde

Roskilde, Denmark

Location

Related Publications (2)

• 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.

  PMID: 40166829 DERIVED

• Glargaard 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.

  PMID: 38245015 DERIVED

MeSH Terms

Conditions

Heart Failure; Pleural Effusion; Heart Failure, Systolic

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Associate Professor, Consultant Cardiologist

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 24, 2021
• Study Start: August 31, 2021
• Primary Completion: March 22, 2024
• Study Completion: December 11, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (10)