POCUS-Guided Diuresis for Heart Failure

(POCUSHF-GD Trial)

Recruiting at 2 trial locations

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?

This trial aims to help people with heart failure manage fluid buildup more effectively. Researchers are testing a new tool that uses ultrasound, which creates images using sound waves, to check fluid levels by measuring a large neck blood vessel. This assists doctors in determining the appropriate amount of diuretics to administer, potentially reducing hospital visits and protecting the kidneys. The trial seeks participants who have recently experienced severe heart failure and are receiving IV diuretics. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance heart failure management.

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.

What prior data suggests that this POCUS-guided diuretic management is safe for heart failure patients?

Research has shown that using POCUS, a bedside ultrasound, to guide diuretic use is safe. Studies indicate that POCUS effectively checks fluid levels in patients with heart failure, aiding doctors in determining the appropriate diuretic dosage to safely remove excess fluid.

Although detailed safety data specifically for POCUS-guided diuretic use is lacking, similar methods in heart failure treatments have been well-tolerated. Patients using these methods have not reported major problems.

Overall, POCUS-guided diuretic treatment appears safe for patients, helping doctors manage fluid levels more effectively and potentially leading to better outcomes for those with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about POCUS-Assessed Diuretic Management for heart failure because it introduces a personalized approach to diuretic treatment. Unlike standard care, which relies solely on clinical evaluation, this method uses Point-of-Care Ultrasound (POCUS) to measure the Right Internal Jugular Vein Distensibility Index, providing real-time data on a patient's fluid status. This targeted insight helps doctors make more informed decisions about diuretic dosing, potentially improving outcomes and reducing hospital stays. By tailoring treatment to individual needs, this approach could revolutionize how heart failure is managed.

What evidence suggests that POCUS-assessed diuretic management could be effective for heart failure?

This trial will compare POCUS-assessed diuretic management with standard diuretic treatment for heart failure patients. Research has shown that POCUS, a bedside ultrasound, aids in managing fluid levels in these patients. Studies have found that checking the flexibility of a neck vein with POCUS allows doctors to adjust water-removing medications more accurately. This method significantly reduces the likelihood of hospital readmission within 30 days by better controlling fluid buildup. It also protects the kidneys by preventing excessive fluid removal. Overall, using POCUS to guide treatment safely and effectively improves care for heart failure patients. ^{1 3 6 7 8}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06921603

POCUS-Guided Diuresis for Decompensated Heart Failure Patients with elevated RAP at discharge were 3.5 times more likely to be readmitted within 30 days. This study introduces POCUS-guided diuretic management in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11044942/

Point of Care Ultrasound for Diagnosis and Management in ... The 5 studies that evaluated HF identification with POCUS found that both diagnostic sensitivity and specificity may reach 90%-100% when IVC ...

3. mdpi.com mdpi.com/2075-4426/14/7/766

Point of Care Ultrasound (POCUS) in the Management ... Point of care ultrasound (POCUS) is an efficient and non-invasive way to assess heart failure patients for volume overload.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0953620525002377

Point of care ultrasound (POCUS) applications in the ... Data was extracted on POCUS intervention characteristics, POCUS applications, as well as outcomes such as validation, feasibility, prognostic ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ehf2.15380

The role of intra‐abdominal pressure and point of care ... The ABDOPOCUS-HF trial investigates whether integrating IAP and POCUS into decongestion strategies improves diuretic response and clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12450796/

The role of intra‐abdominal pressure and point of care ... The ABDOPOCUS‐HF trial investigates whether integrating IAP and POCUS into decongestion strategies improves diuretic response and clinical ...

7. withpower.com withpower.com/trial/phase-acute-kidney-injury-4-2025-d3148

POCUS-Guided Diuresis for Heart Failure The research does not provide specific safety data for POCUS-Guided Diuresis, but studies on similar diuretic treatments for heart failure suggest they are ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06887179?cond=Congestive%20Heart%20Failure&term=focused%20ultrasound&aggFilters=status:not%20rec&rank=5

Point-of-Care Ultrasound in Chronic Heart Failure This study evaluates whether an HF-focused POCUS protocol can enhance congestion assessment in ambulatory HF patients following hospitalization. During a follow ...