216 Participants NeededMy employer runs this trial

Thoracentesis for Heart Failure

(DRAIN-IT Trial)

AC
Overseen ByAmit Chopra, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether thoracentesis, a procedure that removes fluid from around the lungs, can reduce shortness of breath in people with congestive heart failure. Researchers compare this procedure with standard medical treatments to determine which better alleviates breathing difficulties. Suitable participants have heart failure with fluid around their lungs visible on an X-ray and symptoms such as swelling in their legs or abdomen. As an unphased trial, this study provides an opportunity to contribute to medical knowledge and potentially find symptom relief.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual medical therapy, as the study compares thoracentesis with medical therapy to medical therapy alone.

What prior data suggests that thoracentesis is safe for patients with heart failure?

Research has shown that thoracentesis, a procedure to remove fluid from around the lungs, presents mixed safety results for people with heart failure. Some studies found that patients undergoing this procedure while hospitalized for heart failure experienced higher rates of death and complications. About one in four patients reported minor issues like pain or discomfort, though these were generally not severe.

While thoracentesis can relieve symptoms like shortness of breath, it also carries some risks. This procedure requires careful consideration, especially for those with heart failure. Patients should consult healthcare providers to weigh the benefits and risks based on their individual health condition.12345

Why are researchers excited about this trial?

Unlike standard treatments for heart failure, which typically involve medications such as ACE inhibitors, beta-blockers, and diuretics, thoracentesis offers a unique approach by directly removing excess fluid from around the lungs. This can provide rapid relief from symptoms like shortness of breath that are often seen in heart failure patients. Researchers are excited about thoracentesis because it could offer quicker symptomatic relief compared to traditional methods, potentially improving patients’ quality of life with fewer systemic side effects.

What evidence suggests that thoracentesis is effective for relieving shortness of breath in congestive heart failure patients?

This trial will compare thoracentesis combined with medical therapy to medical therapy alone for heart failure patients. Research has shown that thoracentesis, a procedure to remove fluid from around the lungs, is often used for heart failure patients with fluid buildup. However, studies have found that thoracentesis does not significantly improve shortness of breath or other health outcomes for patients with sudden heart failure. For instance, one trial found no major benefits of thoracentesis compared to standard medical treatment alone. Another study showed no improvement in short-term outcomes like hospital stay length or quality of life. Overall, current evidence suggests that thoracentesis may not provide additional relief for symptoms in heart failure patients.12456

Are You a Good Fit for This Trial?

This trial is for adults hospitalized with worsening heart failure who have a moderate to large amount of fluid around their lungs (pleural effusion) seen on X-ray, signs of extra fluid in the body, and certain blood test results. They must have had an ultrasound of the heart recently.

Inclusion Criteria

I am over 18 years old.
I have acute heart failure with signs of fluid buildup like swelling or fluid in my lungs.
* Assessment of left ventricular ejection fraction (LVEF) by echocardiography performed during the time of index hospitalization or within 3 months prior to enrollment
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive medical therapy with or without thoracentesis

30 days
In-hospital treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including telephonic assessments at day 14 and 30

90 days
Telephonic calls at day 14 and 30

What Are the Treatments Tested in This Trial?

Interventions

  • Thoracentesis

Trial Overview

The study compares standard medical treatment alone versus standard treatment plus thoracentesis—a procedure that removes fluid from around the lungs—to see which better relieves shortness of breath in people with heart failure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: InterventionalExperimental Treatment1 Intervention
Group II: Medical TherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials
96
Recruited
12,700+

Citations

Thoracentesis to Alleviate Cardiac Pleural Effusion

The present study will examine the comparative effectiveness of two treatment strategies currently used in the treatment of patients with systolic heart ...

Outcomes of Thoracentesis for Acute Heart Failure in ...

THR performed during HF hospitalizations were associated with higher rates of in-hospital mortality, complications and increased healthcare utilization.

A Randomized Controlled Trial of Thoracentesis in Acute ...

The potential benefits of thoracentesis could have been reduced if the effusions were too small. Observational studies on the impact of ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40166829/

A Randomized Controlled Trial of Thoracentesis in Acute ...

A strategy of upfront routine thoracentesis in addition to standard medical therapy did not increase days alive out of the hospital for 90 days, all-cause ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38245015/

Thoracentesis to alleviate pleural effusion in acute heart ...

Key secondary outcomes include 90-day mortality, complications, readmissions, and quality of life. Ethics and dissemination: The study has been ...

Thoracentesis to alleviate pleural effusion in acute heart failure

Patient-reported outcomes include overall satisfaction with the admission and KCCQ score. Outcomes regarding safety are defined as the ...