An interventional study of Thoracentesis in Congestive Heart Failure(CHF) and Pleural Effusion Due to Congestive Heart Failure, sponsored by Albany Medical College. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Albany Medical College · Not applicable, Interventional, and Treatment
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 :
Congestive heart failure (CHF) is the most common cause of pleural effusions.The presence of clinically significant pleural effusions in hospitalized patients with CHF has been associated with increased hospital length of stay and mortality.The treatment of CHF-related pleural effusion (CHF-PE) typically involves heart failure management such as diuresis. The role of therapeutic thoracentesis in managing heart failure-related effusions is not well established. There is only one randomized controlled trial that assessed the effect of therapeutic thoracentesis in patients with reduced left ventricular ejection fraction (≤45%) and a sizable pleural effusion. This study showed that upfront large volume thoracentesis in addition to medical therapy did not result in improved outcomes, including median days alive out of the hospital over 90 days, hospital length of stay, mortality, or quality of life. However, this trial excluded patients with heart failure with preserved ejection fraction (HFpEF). Few studies show that HFpEF is a more common and prevalent cause of heart failure-related pleural effusion as compared to those with heart failure with reduced ejection fraction (HFrEF).
In this randomized controlled trial, the investigators will compare the clinical outcomes of hospitalized patients with acute decompensated heart failure and pleural effusion who receive therapeutic thoracentesis in addition to medical therapy as compared to the no thoracentesis group.
Primary objective of this study is to assess the effect of upfront therapeutic thoracentesis in addition to the medical therapy in hospitalized patients with acute decompensated heart failure and moderate to large effusion on degree of dyspnea relief as measured by VAS score
Secondary objectives are to examine the effect of thoracentesis on secondary outcomes such as index hospital length of stay, 90-day hospital free survival, quality of life, hospital readmission rate at 90 days and complications related to thoracentesis.
Exclusion Criteria:
Thoracentesis and medical therapy
Procedure: Thoracentesis
Only medical therapy
pleural fluid will be removed
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.
Time frame: 30 days
Proportion of patients achieved clinically significant decrease in mean VAS dyspnea score
Proportion of patients achieved clinically significant decrease in mean VAS dyspnea score over the first 30 days after the enrollment
Time frame: 30 days
Bendopnea
Patient will be instructed to bend forward at the waist and aim to touch ankles and maintain this position for 60 seconds. Patient will inform the investigator as soon as the dyspnea occurs, and the time of onset of bendopnoea and degree of dyspnea will be recorded.
Time frame: 5 days
Quality of life- KCCQ12
The investigators will use Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to assess quality of life. This is based on 12 questions. Score ranges from 0 to 100. Higher score means better health.
Time frame: 30 days
Hospital free day at day 90
Number of hospital-free days at day 90 post-randomization, defined as the total number of days alive and not hospitalized from the date of randomization to 90 days
Time frame: 90 days
All-cause mortality
All cause mortality
Time frame: 90 days
Adverse events
Complications related to thoracentesis (Hemothorax, pneumothorax, need for additional pleural procedures) or medical therapy.
Time frame: upto 30 days
Plan to share: Yes
Supporting information: Study protocol, Sap
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Albany Medical College