RecruitingNot Applicable

DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs

United States216 participantsStarted 2026-02-15

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 dia…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dyspnea

Timeframe: 30 days

Trial details

NCT IDNCT07419360

SponsorAlbany Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02

Contact for this trial

Amit Chopra, MD

646-266-9476 chopraa1@amc.edu

View on ClinicalTrials.gov More Congestive Heart Failure(CHF) trials