Thoracentesis to remove lung fluid for adults hospitalized with worsening heart failure and pleural effusion

Role of Therapeutic Thoracentesis in Hospitalized Patients With Acute Decompensated Heart Failure: Randomized Controlled Trial

This study will test whether removing fluid around the lungs with thoracentesis plus usual heart-failure treatment helps reduce shortness of breath in adults hospitalized with acute decompensated heart failure and moderate-to-large pleural effusions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Albany Medical College (Academic / other)
• Locations: 1 site (Albany, New York)
• Trial ID: NCT07419360 on ClinicalTrials.gov

What this trial studies

Hospitalized adults with acute decompensated heart failure and radiographic moderate-to-large pleural effusions are randomized to receive either therapeutic thoracentesis plus usual medical therapy or usual medical therapy alone. Breathlessness and quality of life are recorded using standard scales before and after the intervention, with follow-up telephone assessments at days 14 and 30. Eligibility requires elevated BNP/NT-proBNP and a recent echocardiographic assessment of left ventricular ejection fraction. The trial compares clinical outcomes including symptom relief and hospital course between the two groups.

Who should consider this trial

Good fit: Adults (over 18) hospitalized with acute decompensated heart failure who have a moderate-to-large pleural effusion on chest X-ray, elevated BNP/NT-proBNP, and a recent echocardiographic LVEF measurement are the intended participants.

Not a fit: Patients with small or loculated effusions, signs suggesting infection or malignancy, unilateral/atypical effusions, or other non-CHF causes of pleural fluid are unlikely to benefit from the thoracentesis approach tested here.

Why it matters

Potential benefit: If successful, the intervention could provide faster relief of shortness of breath and potentially shorten hospital stays for affected patients.

How similar studies have performed: One prior randomized trial in patients with reduced ejection fraction showed no clear benefit from upfront large-volume thoracentesis, so the approach is still unproven and especially understudied in those with preserved ejection fraction.

Eligibility criteria

Inclusion Criteria:

* Adult patients age \>18 years and.
* Clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload (e.g., peripheral edema, pleural effusion, or ascites) and
* Assessment of left ventricular ejection fraction (LVEF) by echocardiography performed during the time of index hospitalization or within 3 months prior to enrollment and
* Serum NT-proBNP level of \>1000 pg/ml or Serum BNP\>250 pg/ml at the time of enrollment and
* Radiographic evidence of moderate to large pleural effusion, defined as pleural fluid occupying more than 1/3rd of the hemithorax on chest X-ray.

Exclusion Criteria:

* Clinical indication for diagnostic thoracentesis - Presence of fever, clinical signs of infection, or atypical pleural effusion for CHF (unilateral left-sided effusion, findings suggestive of malignancy, infection, or alternative etiologies) or.
* Loculated pleural effusion - Evidence of loculated pleural effusion on thoracic ultrasound, as defined as the presence of septations or complex homogenous echogenic fluid (see Imaging Assessment section) or.
* Clinical indication for therapeutic thoracentesis - Presence of massive pleural effusion with acute respiratory failure requiring positive pressure ventilation, high-flow oxygen therapy (\>15 liters per minute of flow), or tension hydrothorax (massive effusion with mediastinal shift and hemodynamic compromise) or.
* Contraindication to thoracentesis, uncontrolled bleeding diathesis, or irreversible INR \> 2.0 and platelet count \<50,000 or.
* Patient with mechanical mitral valve, where anticoagulation cannot be safely held or.
* Pleural procedure, such as but not limited to thoracentesis, chest tube placement, or thoracoscopy, within 3 months prior to enrollment or.
* Cardiac or thoracic surgery within 3 months prior to enrollment or.
* Requirement for chronic renal replacement therapy, such as hemodialysis or peritoneal dialysis or.
* Pregnancy or
* Inability or unwillingness to provide informed consent, or current incarceration (prisoners).

Where this trial is running

Albany, New York

• Albany Medical Center — Albany, New York, United States (Recruiting)

Study contacts

• Study coordinator: Amit Chopra, MD

Conditions Congestive Heart Failure; Pleural Effusion Due to Congestive Heart Failure; congestive heart failure; pleural effusion; dyspnea; hospital length of stay