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| ID | Type | Description | Link |
|---|---|---|---|
| No funding | Other Identifier | Albany medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Thoracentesis and medical therapy |
|
| Medical Therapy | No Intervention | Only medical therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracentesis | Procedure | pleural fluid will be removed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Bendopnea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amit Chopra, MD | Contact | 646-266-9476 | chopraa1@amc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center | Recruiting | Albany | New York | 12211 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D010996 | Pleural Effusion |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000069258 | Thoracentesis |
| ID | Term |
|---|---|
| D019152 | Paracentesis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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.
| 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. | 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 | 90 days |
| All-cause mortality | All cause mortality | 90 days |
| Adverse events | Complications related to thoracentesis (Hemothorax, pneumothorax, need for additional pleural procedures) or medical therapy. | upto 30 days |
| D012120 |
| Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |