Ultrasound for Heart Failure

(BUDS-HF Trial)

Overseen By Om Kothari, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Liver disease, Dialysis, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3-10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new five-point ultrasound can better predict and manage fluid build-up in people with congestive heart failure (CHF). The researchers aim to determine if ultrasound-guided treatment can reduce the risk of heart failure worsening compared to usual care methods, which rely on lab tests and physical exams. Participants will be divided into two groups: one using ultrasound results to guide treatment and the other receiving standard care without ultrasound guidance. This trial may suit individuals diagnosed with heart failure who experience fluid overload and are treated at Boston Medical Center. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve future heart failure treatments.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this five-point ultrasound is safe for heart failure patients?

Research shows that ultrasound guidance in diuretic treatment for heart failure patients could be beneficial. Some studies have used similar ultrasound methods to manage fluid levels in the body, indicating that ultrasound is generally safe for patients. It allows doctors to assess fluid in the lungs and veins, aiding in medication adjustments to remove excess fluid.

Although evidence on this specific five-point ultrasound method is limited, other ultrasound-guided approaches have not revealed major safety issues. Patients have generally tolerated these methods well, suggesting that the five-point ultrasound might also be safe for guiding heart failure treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using five-point ultrasound for heart failure because it offers a new way to guide treatment by directly assessing venous congestion. Unlike the standard approach, which relies on clinical judgment and other imaging techniques, this method uses ultrasound to provide real-time insights, potentially leading to more precise and effective diuresis. This technique could enhance decision-making and optimize fluid management, which is crucial for patients with heart failure. By offering a tailored approach, it holds the promise of improving outcomes and reducing hospitalizations.

What evidence suggests that this ultrasound method is effective for heart failure?

This trial will compare the effectiveness of five-point ultrasound-guided diuresis with the standard of care in managing fluid buildup in heart failure patients. Studies have shown that using a five-point ultrasound to guide fluid removal can be beneficial. Managing fluid buildup is crucial for these patients, as it can worsen symptoms and increase hospital visits. Research indicates that ultrasound allows doctors to identify fluid accumulation, simplifying treatment. This method has shown promise in maintaining patient health and reducing the need for frequent hospital visits. Reducing fluid buildup can improve symptoms and quality of life for those with heart failure. ^{3 6 7 8 9}

Who Is on the Research Team?

Deepa M Gopal, MD

Principal Investigator

Boston Medical Center, Cardiovascular Medicine/Heart Failure

Aala Jaberi, MD

Principal Investigator

Boston Medical Center, Nephrology Section

Are You a Good Fit for This Trial?

This trial is for diverse patients at Boston Medical Center with volume overload or congestive heart failure exacerbation. It's designed to see if a new five-point ultrasound can better predict and manage their condition compared to the usual care methods.

Inclusion Criteria

I am okay with getting regular ultrasounds of my belly and chest while in the hospital.

I have heart failure affecting the right or left side of my heart.

I have worsening heart failure and am getting treatment at BMC.

Exclusion Criteria

Medical condition precluding abdominal ultrasound due to significant discomfort or pain

I have severe kidney problems or need dialysis.

I have not had abdominal surgery in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive diuresis guided by either five-point ultrasound or standard of care for heart failure exacerbation

3-10 days

Inpatient or outpatient visits as needed

Follow-up

Participants are monitored for hospital readmission rates and renal function post-discharge

4 weeks

Extended Follow-up

Participants are monitored for 30-day and 90-day hospital readmission rates and mortality

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Five-point ultrasound

Trial Overview The study is testing whether a novel five-point ultrasound technique can more accurately identify and guide treatment for patients suffering from volume overload due to heart failure, as opposed to standard care which relies on lab markers and physical exams.

How Is the Trial Designed?

Group I: Five-point ultrasound guided diuresis Experimental Treatment 2 Interventions

Participants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care.

Group II: Standard of care guided diuresis Active Control 2 Interventions

Participants randomized to this study arm will have their diuresis clinically guided by standard of care. They will also have five point ultrasound but the results will not inform their diuresis.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5170880/

Point-of-Care, Ultraportable Echocardiography Predicts ... Keywords: ultraportable echocardiography, cardiac ultrasound, heart failure ... Effective use of loop diuretics in heart failure exacerbation: a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06465498

Investigating ACute HeArt FailuRe Decongestion Guided ... It has shown clinical benefits when used to guide decongestive therapy in chronic heart failure ambulatory patients. However, data for its use in AHF inpatients ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213177924003342

Intrapatient Comparison of 3 Diuretic Regimens (DEA-HF) Limited evidence exists regarding efficacy and safety of diuretic regimens in ambulatory, congestion-refractory, chronic heart failure (CHF) patients.

4. trial.medpath.com trial.medpath.com/clinical-trial/8bf935a02b5763ca/ultrasound-guided-diuresis-heart-failure

POCUS-Guided Diuresis for Decompensated Heart Failure If successful, this approach has the potential to help heart failure patients stay healthier, reduce hospital visits, and lower healthcare costs. Detailed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10924023/

Diuretic Treatment in Patients with Heart Failure Fluid retention or congestion is a major cause of symptoms, poor quality of life, and adverse outcome in patients with heart failure (HF).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06921603

POCUS-Guided Diuresis for Decompensated Heart Failure If successful, this approach has the potential to help heart failure patients stay healthier, reduce hospital visits, and lower healthcare costs. Detailed ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9409707/

The Effects of a Therapeutic Strategy Guided by Lung ... Background: Pulmonary congestion (PC) is associated with an increased risk of hospitalization and death in patients with heart failure (HF).

8. heartandlung.org heartandlung.org/article/S0147-9563(24)00191-2/abstract

LUDT-ADHF trial: Lung ultrasound-guided diuretic therapy ... Pulmonary congestion is a critical predictor in heart failure patients, significantly impacting mortality and hospitalization rates.

9. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073521

A Randomized Controlled Trial of Thoracentesis in Acute ... Outcomes of thoracentesis for acute heart failure ... Lung ultrasound-guided therapeutic thoracentesis in refractory congestive heart failure.