Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 10:43 AM
Study NCT ID:
NCT07419360
Status:
RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs
Sponsor:
Albany Medical College
Organization:
Study Overview
Official Title:
Role of Therapeutic Thoracentesis in Hospitalized Patients With Acute Decompensated Heart Failure: Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DRAIN-IT
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
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| No funding | OTHER | Albany medical Center | View |