Thoracentesis to Alleviate Cardiac Pleural Effusion

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

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

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:

• Known or suspected malignant disease

• 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 acute renal failure

• Inability to give informed consent