DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs

NCT07419360 | Recruiting DMC

• 2 other identifiers: AMC IRB# 7327No funding
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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. 1.Receive medical therapy with or without thoracentesis
2. 2.Record degree of shortness of breath and quality of life before and after the intervention using predefined standard scales.
3. 3.Telephonic call for 15- 30 mins at day 14 and 30 after enrollment to assess shortness of breath and quality of life

Conditions

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

Keywords

congestive heart failure; pleural effusion; dyspnea; hospital length of stay

Outcome Measures

Primary Outcomes (1)

• Dyspnea

  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.

  30 days

Secondary Outcomes (6)

• Proportion of patients achieved clinically significant decrease in mean VAS dyspnea score

  30 days

• Bendopnea

  5 days

• Quality of life- KCCQ12

  30 days

• Hospital free day at day 90

  90 days

• All-cause mortality

  90 days

Study Arms (2)

Interventional

EXPERIMENTAL

Thoracentesis and medical therapy

Procedure: Thoracentesis

Medical Therapy

NO INTERVENTION

Only medical therapy

Interventions

Thoracentesis PROCEDURE

pleural fluid will be removed

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12211, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Pleural Effusion; Dyspnea

Interventions

Thoracentesis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pleural Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Amit Chopra, MD

CONTACT

646-266-9476; chopraa1@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 19, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)