Congestive Heart Failure(CHF)DRAIN-ITNCT07419360
DRAIN: DRainage in Acute Decompensated Heart faIlure With Pleural effusioNs
A study testing Thoracentesis in people with Congestive Heart Failure(CHF) and Pleural Effusion Due to Congestive Heart Failure, run by Albany Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure(CHF), Pleural Effusion Due to Congestive Heart Failure
- What is being tested?
- Thoracentesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Albany Medical Center
Albany, New York, 12211
Katy, 518-262-5693, ReganK@amc.edu
About this study
Official title: Role of Therapeutic Thoracentesis in Hospitalized Patients With Acute Decompensated Heart Failure: Randomized Controlled Trial
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.
Read more
Participants will :
- Receive medical therapy with or without thoracentesis
- Record degree of shortness of breath and quality of life before and after the intervention using predefined standard scales.
- Telephonic call for 15- 30 mins at day 14 and 30 after enrollment to assess shortness of breath and quality of life
Read the 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.
- Being tested
- Thoracentesis
- Keywords
- congestive heart failure, pleural effusion, dyspnea, hospital length of stay
- Medical subject headings
- Heart Failure, Pleural Effusion, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracentesisProcedure or surgery
pleural fluid will be removed
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Thoracentesis and medical therapy Receives: Procedure: Thoracentesis |
| Medical Therapy | No intervention | Only medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 90 days
All-cause mortality
All cause mortality
Measured: 90 days
Adverse events
Complications related to thoracentesis (Hemothorax, pneumothorax, need for additional pleural procedures) or medical therapy.
Measured: upto 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start15 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure(CHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Chopra, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419360
- Sponsor's protocol ID
- AMC IRB# 7327
- Other IDs
- No funding
- Acronym
- DRAIN-IT
- Status last verified
- Apr 2026
- First submitted
- 28 Jan 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Therapeutic Thoracentesis in Hospitalized Patients With Acute Decompensated Heart Failure: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07419360
- Acronym / sponsor ID
- DRAIN-IT / AMC IRB# 7327
- Keywords
- congestive heart failure, pleural effusion, dyspnea, hospital length of stay
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Receive medical therapy with or without thoracentesis
- Record degree of shortness of breath and quality of life before and after the intervention using predefined standard scales.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: ThoracentesisThoracentesis and medical therapy |
| Medical Therapy | No intervention | –Only medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracentesispleural fluid will be removed | Procedure or surgery | Interventional |
Primary outcome
Dyspnea
Time frame: 30 days
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.
6 secondary outcomes
Proportion of patients achieved clinically significant decrease in mean VAS dyspnea score
Time frame: 30 days
Bendopnea
Time frame: 5 days
Quality of life- KCCQ12
Time frame: 30 days
Hospital free day at day 90
Time frame: 90 days
All-cause mortality
Time frame: 90 days
Adverse events
Time frame: upto 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Congestive Heart Failure(CHF)
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracentesis in people with Congestive Heart Failure(CHF) and Pleural Effusion Due to Congestive Heart Failure, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amit Chopra, MD (646-266-9476, chopraa1@amc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.