Actively Recruiting
Role of Therapeutic Thoracentesis in Hospitalized Patients With Acute Decompensated Heart Failure: Randomized Controlled Trial
Led by Albany Medical College · Updated on 2026-04-30
216
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare treatments for hospitalized patients with acute decompensated heart failure who have moderate to large pleural effusions. The study evaluates whether removing fluid around the lungs through a procedure called thoracentesis, combined with medical therapy, is better at relieving shortness of breath than medical therapy alone. The trial includes patients with both reduced and preserved heart pumping function, addressing a gap left by earlier studies. Participants will be randomly assigned to receive either thoracentesis plus medical therapy or medical therapy alone. Thoracentesis involves removing pleural fluid, and medical therapy follows standard heart failure management. The study monitors effects on breathing difficulty, hospital stay length, survival without hospitalization up to 90 days, quality of life, readmission rates, and any complications from thoracentesis. During the study, participants will report their shortness of breath and quality of life using standard scales before and after treatment. Follow-up includes phone calls at days 14 and 30 to assess symptoms and quality of life. The main outcome measured is relief of dyspnea at 30 days, with additional monitoring for hospital-free days and mortality at 90 days. Safety and adverse events related to thoracentesis are tracked up to 30 days after enrollment.
CONDITIONS
Brief Title
DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients age >18 years
- Clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload such as peripheral edema, pleural effusion, or ascites
- Assessment of left ventricular ejection fraction by echocardiography during current hospitalization or within 3 months prior
- Serum NT-proBNP level >1000 pg/ml or Serum BNP >250 pg/ml at enrollment
- Radiographic evidence of moderate to large pleural effusion occupying more than one-third of the hemithorax on chest X-ray
You will not qualify if you...
- Clinical indication for diagnostic thoracentesis due to fever, infection signs, or atypical pleural effusion suggestive of other causes
- Loculated pleural effusion shown by thoracic ultrasound with septations or complex fluid
- Massive pleural effusion causing acute respiratory failure needing high oxygen support or tension hydrothorax
- Contraindications to thoracentesis including uncontrolled bleeding, INR > 2.0, or platelet count <50,000
- Mechanical mitral valve with unsafe anticoagulation management
- Pleural procedure such as thoracentesis, chest tube, or thoracoscopy within 3 months
- Cardiac or thoracic surgery within 3 months
- Need for chronic renal replacement therapy like dialysis
- Pregnancy
- Inability or unwillingness to provide informed consent or current incarceration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of hospitalization
Participants receive therapeutic thoracentesis in addition to medical therapy or medical therapy alone to manage pleural effusion related to acute decompensated heart failure.
1 hospital stay with treatment procedures
Duration - Up to 90 days
Participants are monitored for up to 90 days after treatment to assess dyspnea relief, hospital readmission, quality of life, and safety outcomes.
Follow-up assessments at multiple timepoints up to 90 days
Trial Site Locations
Total: 1 location
1
Albany Medical Center
Albany, New York, United States, 12211
Actively Recruiting
Research Team
A
Amit Chopra, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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