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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Albany Medical Center
  Albany, New York, United States Recruiting

Study contacts

• Study coordinator: Amit Chopra, MD
• Email: chopraa1@amc.edu
• Phone: 646-266-9476

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.