Study Results
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Basic Information
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RECRUITING
NA
588 participants
INTERVENTIONAL
2025-06-29
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
University of Pittsburgh
OTHER
Responsible Party
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John Pacella
Professor of Medicine
Principal Investigators
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John J Pacella, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center (UPMC)
Locations
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Abstract 12544: Point-of-Care Ultrasound Estimation of Right Atrial Pressure Predicts Early Readmission in Patients With Acute Decompensated Heart Failure
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Other Identifiers
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25POST1361664
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY24090092
Identifier Type: -
Identifier Source: org_study_id
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