Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07419360

DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs

Led by Albany Medical College · Updated on 2026-04-30

216

Participants Needed

1

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to assess if removal of fluid around the lungs (pleural effusion) by a routine procedure called as thoracentesis is helpful to decrease shortness of breath in hospitalized patients with congestive heart failure and have pleural effusion. Researchers will compare thoracentesis with medical therapy to medical therapy alone to see if one treatment is superior to the other treatment in relieving shortness of breath. Participants will : 1. Receive medical therapy with or without thoracentesis 2. Record degree of shortness of breath and quality of life before and after the intervention using predefined standard scales. 3. Telephonic call for 15- 30 mins at day 14 and 30 after enrollment to assess shortness of breath and quality of life

CONDITIONS

Official 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 index 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 1/3rd 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 not typical for CHF
  • Loculated pleural effusion with septations or complex echogenic fluid on thoracic ultrasound
  • Clinical indication for therapeutic thoracentesis with massive effusion causing acute respiratory failure needing ventilation or high-flow oxygen >15 liters/min, or tension hydrothorax
  • Contraindication to thoracentesis such as uncontrolled bleeding, INR > 2.0, platelet count <50,000
  • Patient with mechanical mitral valve where anticoagulation cannot be safely held
  • Pleural procedure like thoracentesis, chest tube, or thoracoscopy within 3 months prior
  • Cardiac or thoracic surgery within 3 months prior
  • Requirement for chronic renal replacement therapy such as 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

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Trial Site Locations

Total: 1 location

1

Albany Medical Center

Albany, New York, United States, 12211

Actively Recruiting

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Research Team

A

Amit Chopra, MD

CONTACT

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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DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs | DecenTrialz