Recruiting

Thoracentesis vs. Medical Therapy

Sponsor:

Albany Medical College

Code:

NCT07419360

Conditions

Congestive Heart Failure(CHF)

Pleural Effusion Due to Congestive Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thoracentesis

Study Details

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. 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

Congestive Heart Failure(CHF)

Pleural Effusion Due to Congestive Heart Failure

Study ID

NCT07419360

Start date

Feb 15, 2026

Status verified date

Apr, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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).

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Interventional

Thoracentesis and medical therapy

no intervention: Medical Therapy

Only medical therapy

Interventions

Thoracentesis

pleural fluid will be removed

Primary outcome measure

  • Dyspnea [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Amit Chopra, MD

646-266-9476chopraa1@amc.edu

Locations

Albany Medical Center

Recruiting

Albany, New York, United States, 12211

Contacts

Katy

518-262-5693ReganK@amc.edu

More Information

Sponsor

Albany Medical College

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Albany Medical College on 2026-04-30.