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DRAIN: Thoracentesis for Heart Failure with Pleural Effusions

This study, called DRAIN, is looking at whether removing fluid from around the lungs (a procedure called thoracentesis) can help hospitalized patients with congestive heart failure (CHF) who also have fluid buildup in their lungs (pleural effusion). Researchers want to see if adding thoracentesis to standard medical care is better at reducing shortness of breath than medical care alone. You could be eligible if you are an adult (over 18) with a diagnosis of acute decompensated heart failure and signs of fluid overload, including pleural effusion. The main goal is to see how much your shortness of breath improves after 30 days. The current status of this study is unclear, and it plans to enroll 216 participants.

Study design
This is an interventional study comparing medical therapy with and without thoracentesis. It plans to enroll 216 participants.
What's involved
You would receive medical therapy, potentially with thoracentesis. You would also record your shortness of breath and quality of life using standard scales, and have two short phone calls at 14 and 30 days after joining.
Compensation
Not stated in the trial record.
Follow-up
Your shortness of breath and quality of life will be assessed at 14 and 30 days after enrollment.

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NCT07419360

DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs

Recruiting
NAAges 18+InterventionalTreatment
Albany Medical College
~216 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:Thoracentesis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dyspnea
Measured over 30 days

Conditions

Congestive Heart Failure(CHF)
Pleural Effusion Due to Congestive Heart Failure

Explore related trials

Congestive Heart FailurePleural Effusion

Where it's being run

1 sites across 1 states
New York1

Who to contact

Amit Chopra, MD
[email protected]
646-266-9476
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Dyspnea30 days

    Degree of dyspnea will be assessed as by using a validated 100 mm visual analog scale in participants of both groups. Dyspnea will be assessed using a 100 mm visual analog scale (VAS). The VAS consisted of a horizontal straight line with endpoints defining extreme limits, with the left end marked as "no trouble" (0 mm) and the right end as "very much trouble" (100 mm). A higher VAS score indicated more severe dyspnea. The minimal clinically important difference (MCID) was defined as ≥ 14 mm improvement on this 100 mm scale, adapted from the established 24-hour VAS dyspnea threshold for clinical practicality in our setting.