Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07419360

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Loading map...

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

Similar Trials

Multiparametric Assessment of Residual Congestion at Dischar...

Acute Heart Failure (AHF)

Actively Recruiting

1 location

Observational Study of the HemoCept Device During Right Hear...

Pulmonary Hypertension

Actively Recruiting

1 location

Implementing Community Palliative Care for People With Heart...

Congestive Heart Failure

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here