POCUS-Guided Diuresis for Heart Failure

(POCUSHF-GD Trial)

Recruiting at 1 trial location

Overseen By Benay Ozbay, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Must be taking: IV diuretics

Disqualifiers: LVAD, Cardiomyopathy, Advanced cancer, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 60 days

588 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Heart failure occurs when the heart cannot pump blood effectively, leading to fluid buildup in the body. This can cause problems such as difficulty breathing, swelling, and extreme tiredness. In severe cases, these symptoms worsen to the point where hospitalization is required. Unfortunately, many patients with severe heart failure are readmitted to the hospital within 30 days after discharge, which is both physically and emotionally challenging for patients and places a significant financial burden on individuals and the healthcare system. Although symptoms such as difficulty breathing and swelling may improve during the hospital stay, some patients are discharged with excess fluid remaining in their bodies. This retained fluid often causes symptoms to worsen, leading to subsequent hospital readmissions. Inadequate management of fluid levels can also harm the kidneys, further complicating the patient's condition. This study aims to improve care for heart failure patients by utilizing a simple, non-invasive tool to assess fluid levels more accurately at the bedside. The tool measures the size of a large blood vessel in the neck, providing key information about the pressure inside the heart. This information enables clinicians to determine the appropriate amount of medication needed to remove just the right amount of fluid. Properly managing fluid levels can help prevent kidney damage and improve overall patient outcomes. The primary goal of this study is to evaluate whether this tool can reduce the number of patients readmitted to the hospital within 30 days of discharge. A secondary goal is to determine whether the tool can help protect kidney function by allowing for better fluid management. If successful, this approach has the potential to help heart failure patients stay healthier, reduce hospital visits, and lower healthcare costs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves treatment with intravenous diuretics, it's best to discuss your current medications with the study team to ensure there are no conflicts.

Is POCUS-Guided Diuresis for Heart Failure safe for humans?

The research does not provide specific safety data for POCUS-Guided Diuresis, but studies on similar diuretic treatments for heart failure suggest they are generally safe when managed properly. ^{1 2 3 4 5}

How is POCUS-Assessed Diuretic Management different from other heart failure treatments?

POCUS-Assessed Diuretic Management is unique because it uses point-of-care ultrasonography (POCUS) to visually assess and guide the treatment of fluid overload in heart failure patients. This approach allows for real-time monitoring of fluid status and helps tailor diuretic therapy more precisely compared to traditional methods that rely on physical examination and standard lab tests. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment POCUS-Assessed Diuretic Management for heart failure?

Research shows that using point of care ultrasonography (POCUS) can help doctors better assess fluid levels in patients with heart failure, which can improve the management of diuretic therapy. This approach has been shown to help identify and monitor congestion, leading to more effective treatment. ^{4 5 6 7 10}

Who Is on the Research Team?

John J Pacella, MD

Principal Investigator

University of Pittsburgh Medical Center (UPMC)

Are You a Good Fit for This Trial?

This trial is for heart failure patients at risk of hospital readmission due to fluid buildup. It's aimed at those who could benefit from improved fluid management to prevent kidney damage and reduce readmissions.

Inclusion Criteria

POCUS Measurement: Must have an abnormal right internal jugular vein (RIJV) distensibility index (DI) of <66% on point-of-care ultrasound (POCUS) at the time of admission

I have been diagnosed with acute decompensated heart failure.

I am scheduled for treatment with IV fluids to remove excess water.

Exclusion Criteria

Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible

I do not have hypertrophic or infiltrative cardiomyopathy.

Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive POCUS-guided diuretic management or standard diuretic treatment during hospitalization

Up to 60 days

Daily POCUS imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on readmission rates and kidney function

30 days post-discharge

Extension

Long-term monitoring of participants for additional outcomes such as mortality and renal function

Up to 60 days

What Are the Treatments Tested in This Trial?

Interventions

• POCUS-Assessed Diuretic Management

Trial Overview The study tests if a non-invasive tool (POCUS) that measures blood vessel size in the neck can guide diuretic treatment better than standard care, potentially reducing hospital readmissions and protecting kidneys.

How Is the Trial Designed?

Group I: POCUS-assessed diuretic management Experimental Treatment 1 Intervention

Participants in this group will undergo daily POCUS imaging to assess volume status. The right internal jugular vein (RIJV) Distensibility Index (DI) will be measured and shared with the clinical team to guide diuretic (intravenous furosemide) management. However, all treatment decisions will be made at the discretion of the treating physicians.

Group II: Furosemide (Standard Diuretic) Treatment Active Control 1 Intervention

Participants in this group will receive intravenous furosemide (standard diuretic) treatment, as part of their routine care, based on clinical evaluation. POCUS imaging will be performed daily for research only, and findings will not be shared with the clinical team. Treatment decisions will follow usual care protocols.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

In a study involving 310 patients with acute heart failure, natriuresis-guided diuretic therapy significantly increased urinary sodium excretion compared to standard care, indicating a potential benefit in monitoring treatment response.

However, despite improved natriuresis, there were no significant differences in clinical outcomes such as all-cause mortality or heart failure rehospitalization between the natriuresis-guided and standard care groups, suggesting that while the approach may enhance sodium excretion, it does not necessarily translate to better overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial. Ter Maaten, JM., Beldhuis, IE., van der Meer, P., et al.[2023]

In the VICTORIA trial, patients with lower left ventricular ejection fraction (LVEF) had higher levels of certain biomarkers and experienced worse clinical outcomes, indicating a more severe heart failure condition.

Vericiguat showed consistent efficacy across different LVEF levels, with the most significant benefit observed in patients with the lowest LVEF (≤24%), suggesting it is a valuable treatment option for patients with varying degrees of heart failure severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ejection Fraction, Biomarkers, and Outcomes and Impact of Vericiguat on Outcomes Across EF in VICTORIA. Butler, J., Zheng, Y., Khan, MS., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Natriuresis-guided diuretic therapy in acute heart failure: a pragmatic randomized trial. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Evaluation of Venous Congestion Using Beside Ultrasonography by the Nephrology Consultant: The VExUS Nexus. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Venous Excess Doppler Ultrasound: A Visual Guide to Decongestion in Cardiorenal Syndrome. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[Ultrasonography of the inferior vena cava (IVC) in the diagnosis and monitoring of therapy in patients with chronic congestive heart failure]. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Association of diuretic treatment at hospital discharge in patients with heart failure with all-cause short- and long-term mortality: A propensity score-matched analysis from SwedeHF. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Ambulatory intravenous furosemide for decompensated heart failure: safe, feasible, and effective. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Ejection Fraction, Biomarkers, and Outcomes and Impact of Vericiguat on Outcomes Across EF in VICTORIA. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Vericiguat: A Novel Soluble Guanylate Cyclase Stimulator for Use in Patients With Heart Failure. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Assessment of Fluid Status by Point-of-Care Ultrasonography. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Spot Urine Sodium as Triage for Effective Diuretic Infusion in an Ambulatory Heart Failure Unit. [2019]