POCUS-Guided Diuresis for Decompensated Heart Failure (POCUSHF-GD)

February 12, 2026 updated by: John Pacella, University of Pittsburgh

Point-of-Care Ultrasound-Guided Diuresis for Acute Decompensated Heart Failure to Reduce 30-Day Readmissions and Acute Kidney Injury

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart failure is a major cause of hospitalization in the United States, affecting over 5 million adults, with 30-day readmission rates as high as 22%. Hospitalizations account for the majority of acute decompensated heart failure (ADHF)-related healthcare costs, and institutions that care for lower-income populations face added pressure under value-based payment models such as the Hospital Readmission Reduction Program (HRRP).

ADHF is characterized by elevated cardiac filling pressures and systemic congestion. Traditional clinical assessments, such as physical examination, chest radiography, and jugular venous pressure (JVP) evaluation, are often limited by low accuracy and high interobserver variability. Residual congestion at discharge is a key predictor of readmission and contributes to complications like acute kidney injury (AKI), which can occur in up to 20% of ADHF hospitalizations and is associated with increased mortality, longer length of stay, and higher healthcare costs (up to $80,400 per patient).

Point-of-care ultrasound (POCUS) has emerged as a valuable bedside tool for non-invasive, real-time volume assessment. This study focuses on a novel application of POCUS that uses the right internal jugular vein (RIJV) to estimate right atrial pressure (RAP). By measuring the cross-sectional area (CSA) of the RIJV during rest and the Valsalva maneuver, the Distensibility Index (DI) can be calculated. A DI ≥66% is associated with low RAP (≤12 mmHg), while lower values indicate persistent venous congestion.

Previous studies support the utility of this method. In a right heart catheterization cohort (n=67), DI predicted elevated RAP with 87% positive predictive value. In a prospective observational cohort (n=274), a DI ≥66% at discharge was associated with a 91.1% negative predictive value for avoiding early readmission. 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 hospitalized ADHF patients. The ultrasound-derived DI will be used to inform decisions regarding diuretic therapy and discharge readiness. All ultrasound operators will receive standardized training to ensure reproducibility of measurements. Clinician adherence to POCUS-guided recommendations will be monitored, and structured feedback will be obtained to assess usability.

By enhancing volume status assessment, this approach aims to improve decongestion strategies, reduce 30-day readmissions, and prevent kidney injury. If successful, this method could be integrated into routine clinical workflows, especially in settings where advanced imaging resources are limited. The study may inform future clinical guidelines and support more individualized, equitable care for patients with heart failure.

Study Type

Interventional

Enrollment (Estimated)

588

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center
        • Principal Investigator:
          • John Pacella, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benay Ozbay, MD
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Shadyside
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Adam Sohnen, MD
        • Sub-Investigator:
          • James Ma, MD
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian
        • Contact:
        • Principal Investigator:
          • Benay Ozbay, MD
      • Pittsburgh, Pennsylvania, United States, 15146
        • Not yet recruiting
        • UPMC East
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hamit Mahamat Chahata, MD
      • Pittsburgh, Pennsylvania, United States, 15219
        • Not yet recruiting
        • UPMC Mercy
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Vanessa Mutch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

List the inclusion criteria:

  1. Age: Patients must be 18 years or older.
  2. Diagnosis: Must have a confirmed diagnosis of acute decompensated heart failure (ADHF).
  3. Treatment Plan: Patients must be planned for treatment with intravenous (IV) diuretics.
  4. 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.

These criteria ensure that participants are appropriately selected for the study and are likely to benefit from POCUS-guided diuretic management.

List the exclusion criteria:

  1. Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments.
  2. Anatomical Incompatibilities: Excludes patients with RIJV or superior vena cava thrombus, congenital heart disease, or severe tricuspid regurgitation, as these conditions may impair accurate POCUS measurements.
  3. Cardiomyopathy: Patients with hypertrophic or infiltrative cardiomyopathy will be excluded.
  4. End-of-Life Care: Patients receiving hospice care or comfort measures only will not be included in the study.
  5. Advanced Cancer: Patients with metastatic cancer will be excluded.
  6. Severe Liver Dysfunction: Patients with a MELD-Na score greater than 20, indicating severe liver dysfunction, will be excluded.
  7. End stage chronic kidney disease
  8. Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible.
  9. Inotropic Support: Patients requiring inotropic support at the time of enrollment will be excluded, as they represent a more severe heart failure profile that may not be suitable for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: POCUS-assessed diuretic management
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.
Other: POCUS-Assessed Diuretic Management
POCUS will be used to provide objective, non-invasive assessments of fluid status by measuring right internal jugular vein (RIJV) cross-sectional area (CSA) and calculating the Distensibility Index (DI). This information will be shared with the treating clinical team as an additional tool for fluid management. However, all final decisions regarding diuretic therapy will be made at the discretion of the treating physicians.
Active Comparator: Furosemide (Standard Diuretic) Treatment
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.
Other: Furosemide (Standard Diuretic) Treatment
Participants in this group will receive intravenous furosemide as part of their routine care, based on clinical assessments including symptoms, physical examination. Daily POCUS imaging will be performed for research purposes; however, the findings will not be shared with the treating clinical team. Fluid management decisions and discharge planning will follow usual care protocols, without additional imaging-based guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-Day Readmission Rate in Acute Decompensated Heart Failure (ADHF) Patients
Time Frame: From date of hospital discharge until date of first readmission for heart failure or 30 days post-discharge, whichever comes first.
The percentage of participants readmitted to the hospital within 30 days of discharge for heart failure-related issues. The outcome compares the readmission rates between the POCUS-assessed diuretic management group and the standard care group.
From date of hospital discharge until date of first readmission for heart failure or 30 days post-discharge, whichever comes first.
Incidence of Acute Kidney Injury (AKI)
Time Frame: From baseline to hospital discharge and up to 30 days post-discharge (if readmitted).

The percentage of participants who develop acute kidney injury (AKI) during hospitalization or within 30 days post-discharge (if readmitted).

Definition: AKI will be defined using the Acute Kidney Injury Network (AKIN) criteria:

  • Increase in serum creatinine by ≥0.3 mg/dL within 48 hours OR
  • Increase in serum creatinine by ≥50% from baseline OR
  • Reduced urine output (<0.5 mL/kg/hr for ≥6 hours).

Outcome Type: Binary (Yes/No)
From baseline to hospital discharge and up to 30 days post-discharge (if readmitted).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-Day Mortality
Time Frame: From date of hospital discharge until date of death from any cause or 30 days post-discharge, whichever comes first.
The percentage of participants who die within 30 days of discharge. This outcome compares mortality rates between the POCUS-assessed and standard care groups.
From date of hospital discharge until date of death from any cause or 30 days post-discharge, whichever comes first.
Length of Hospital Stay
Time Frame: From the date of hospital admission until the date of hospital discharge, assessed up to 60 days.
The duration of hospitalization in days, measured for both groups.
From the date of hospital admission until the date of hospital discharge, assessed up to 60 days.
Renal Function at Discharge
Time Frame: From date of hospital admission (baseline assessment) until date of hospital discharge, assessed up to 60 days.
Change in eGFR (mL/min/1.73m²) from baseline to discharge to assess kidney function.
From date of hospital admission (baseline assessment) until date of hospital discharge, assessed up to 60 days.
Adherence to POCUS-Based Recommendations
Time Frame: From date of hospital admission until date of hospital discharge, assessed up to 60 days.
Percentage of cases in the POCUS-Assessed Group where clinicians followed POCUS-based recommendations for diuretic management.
From date of hospital admission until date of hospital discharge, assessed up to 60 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

American Heart Association

Investigators

  • Principal Investigator: John J Pacella, MD, University of Pittsburgh Medical Center (UPMC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24090092
  • 25POST1361664 (Other Grant/Funding Number: American Heart Association)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) collected in this study, including baseline characteristics, clinical outcomes, and POCUS measurements, will be shared. Data will be available upon reasonable request for researchers conducting methodologically sound studies that align with the objectives of this research.

IPD Sharing Time Frame

IPD and supporting documents will be available starting 6 months after publication of the primary results and will remain accessible for 5 years thereafter.

IPD Sharing Access Criteria

Access to the dataset will be granted to researchers upon submission of a formal request, outlining the study objectives and analysis plan. Approval will be contingent upon compliance with ethical guidelines, data privacy regulations, and institutional review board (IRB) requirements. Researchers will be required to sign a data-sharing agreement (DSA) before receiving access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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