Heart Decompensation, AcutePOCUSHF-GDNCT06921603
POCUS-Guided Diuresis for Decompensated Heart Failure
A study testing Furosemide (Standard Diuretic) Treatment and POCUS-Assessed Diuretic Management in people with Heart Decompensation, Acute and Acute Kidney Injuries, run by University of Pittsburgh at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Decompensation, Acute, Acute Kidney Injuries
- What is being tested?
- Furosemide (Standard Diuretic) Treatment and POCUS-Assessed Diuretic Management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
List the inclusion criteria:
- Age: Patients must be 18 years or older.
- Diagnosis: Must have a confirmed diagnosis of acute decompensated heart failure (ADHF).
- Treatment Plan: Patients must be planned for treatment with intravenous (IV) diuretics.
- 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:
- Left Ventricular Assist Devices (LVAD): Patients with LVADs will be excluded due to their unique hemodynamics, which may interfere with study assessments.
- 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.
- Cardiomyopathy: Patients with hypertrophic or infiltrative cardiomyopathy will be excluded.
- End-of-Life Care: Patients receiving hospice care or comfort measures only will not be included in the study.
- Advanced Cancer: Patients with metastatic cancer will be excluded.
- Severe Liver Dysfunction: Patients with a MELD-Na score greater than 20, indicating severe liver dysfunction, will be excluded.
- End stage chronic kidney disease
- Inability to Provide Consent: Patients who are unable to provide informed consent, due to cognitive impairment or other reasons, will not be eligible.
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
UPMC East
Pittsburgh, Pennsylvania, 15146
Benay Ozbay, MD, 4124502774, ozbayb@upmc.edu
Benay Ozbay, MD, 412-450-2774, ozbayb@upmc.edu
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
John J Pacella, MD, 4127805529, pacellajj@upmc.edu
Benay Ozbay, MD, 4124502774, benayozbay@hotmail.com
- Recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Benay Ozbay, MD, 4124502774, benayozbay@hotmail.com
Benay Ozbay, MD
- Not yet recruiting
UPMC Mercy
Pittsburgh, Pennsylvania, 15219
Benay Ozbay, MD, 4124502774, ozbayb@upmc.edu
Benay Ozbay, MD, 412-450-2774, ozbayb@upmc.edu
- Recruiting
UPMC Shadyside
Pittsburgh, Pennsylvania, 15232
Adam Sohnen, MD, 412-624-4170, sohnae@upmc.edu
Benay Ozbay, MD, 412-450-2774, benayozbay@hotmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Heart Decompensation, Acute, Acute Kidney Injuries
- Being tested
- Furosemide (Standard Diuretic) Treatment, POCUS-Assessed Diuretic Management
- Keywords
- heart failure, point-of-care-ultrasound, readmission, acute kidney injury
- Medical subject headings
- Heart Failure, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide (Standard Diuretic) TreatmentOther
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 ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| POCUS-assessed diuretic management | Experimental | 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. Receives: Other: POCUS-Assessed Diuretic Management |
| Furosemide (Standard Diuretic) Treatment | Active comparator | 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. Receives: Other: Furosemide (Standard Diuretic) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day Readmission Rate in Acute Decompensated Heart Failure (ADHF) Patients
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.
Measured: 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)
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)
Measured: From baseline to hospital discharge and up to 30 days post-discharge (if readmitted).
Secondary outcomes (4)
30-Day Mortality
The percentage of participants who die within 30 days of discharge. This outcome compares mortality rates between the POCUS-assessed and standard care groups.
Measured: From date of hospital discharge until date of death from any cause or 30 days post-discharge, whichever comes first.
Length of Hospital Stay
The duration of hospitalization in days, measured for both groups.
Measured: From the date of hospital admission until the date of hospital discharge, assessed up to 60 days.
Renal Function at Discharge
Change in eGFR (mL/min/1.73m²) from baseline to discharge to assess kidney function.
Measured: From date of hospital admission (baseline assessment) until date of hospital discharge, assessed up to 60 days.
Adherence to POCUS-Based Recommendations
Percentage of cases in the POCUS-Assessed Group where clinicians followed POCUS-based recommendations for diuretic management.
Measured: From date of hospital admission until date of hospital discharge, assessed up to 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start29 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Heart Decompensation, AcuteStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into two groups: a POCUS-assessed group and a standard care control group. Each group follows separate management protocols during the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 588 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, John Pacella, University of Pittsburgh
- Investigators
- John J Pacella, MD, Principal investigator, University of Pittsburgh Medical Center (UPMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921603
- Sponsor's protocol ID
- STUDY24090092
- Other IDs
- 25POST1361664
- Acronym
- POCUSHF-GD
- Status last verified
- Feb 2026
- First submitted
- 26 Mar 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kim WR, Biggins SW, Kremers WK, Wiesner RH, Kamath PS, Benson JT, Edwards E, Therneau TM. Hyponatremia and mortality among patients on the liver-transplant waiting list. N Engl J Med. 2008 Sep 4;359(10):1018-26. doi: 10.1056/NEJMoa0801209.
PubMed 18768945Abstract 12544: Point-of-Care Ultrasound Estimation of Right Atrial Pressure Predicts Early Readmission in Patients With Acute Decompensated Heart Failure
Heldeweg MLA, Jagesar AR, Haaksma ME, Smit JM, Paulus F, Schultz MJ, Tuinman PR. Effects of Lung Ultrasonography-Guided Management on Cumulative Fluid Balance and Other Clinical Outcomes: A Systematic Review. Ultrasound Med Biol. 2021 May;47(5):1163-1171. doi: 10.1016/j.ultrasmedbio.2021.01.024. Epub 2021 Feb 23.
PubMed 33637390Yampolsky S, Kwan A, Cheng S, Kedan I. Point of Care Ultrasound for Diagnosis and Management in Heart Failure: A Targeted Literature Review. POCUS J. 2024 Apr 22;9(1):117-130. doi: 10.24908/pocus.v9i1.16795. eCollection 2024.
PubMed 38681155Chaudhary R, Sukhi A, Simon MA, Villanueva FS, Pacella JJ. Role of Internal Jugular Venous Ultrasound in suspected or confirmed Heart Failure: A Systematic Review. J Card Fail. 2022 Apr;28(4):639-649. doi: 10.1016/j.cardfail.2021.08.009. Epub 2021 Aug 19.
PubMed 34419599Allen LA, Smoyer Tomic KE, Smith DM, Wilson KL, Agodoa I. Rates and predictors of 30-day readmission among commercially insured and Medicaid-enrolled patients hospitalized with systolic heart failure. Circ Heart Fail. 2012 Nov;5(6):672-9. doi: 10.1161/CIRCHEARTFAILURE.112.967356. Epub 2012 Oct 16.
PubMed 23072736Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
PubMed 35379503Njoroge JN, Teerlink JR. Pathophysiology and Therapeutic Approaches to Acute Decompensated Heart Failure. Circ Res. 2021 May 14;128(10):1468-1486. doi: 10.1161/CIRCRESAHA.121.318186. Epub 2021 May 13.
PubMed 33983837Heidenreich PA, Fonarow GC, Opsha Y, Sandhu AT, Sweitzer NK, Warraich HJ; HFSA Scientific Statement Committee Members Chair. Economic Issues in Heart Failure in the United States. J Card Fail. 2022 Mar;28(3):453-466. doi: 10.1016/j.cardfail.2021.12.017. Epub 2022 Jan 24.
PubMed 35085762Psotka MA, Fonarow GC, Allen LA, Joynt Maddox KE, Fiuzat M, Heidenreich P, Hernandez AF, Konstam MA, Yancy CW, O'Connor CM. The Hospital Readmissions Reduction Program: Nationwide Perspectives and Recommendations: A JACC: Heart Failure Position Paper. JACC Heart Fail. 2020 Jan;8(1):1-11. doi: 10.1016/j.jchf.2019.07.012. Epub 2019 Oct 9.
PubMed 31606360Lahewala S, Arora S, Tripathi B, Panaich S, Kumar V, Patel N, Savani S, Dave M, Varma Y, Badheka A, Deshmukh A, Gidwani U, Gopalan R, Briasoulis A. Heart failure: Same-hospital vs. different-hospital readmission outcomes. Int J Cardiol. 2019 Mar 1;278:186-191. doi: 10.1016/j.ijcard.2018.12.043. Epub 2018 Dec 15.
PubMed 30579719Urbich M, Globe G, Pantiri K, Heisen M, Bennison C, Wirtz HS, Di Tanna GL. A Systematic Review of Medical Costs Associated with Heart Failure in the USA (2014-2020). Pharmacoeconomics. 2020 Nov;38(11):1219-1236. doi: 10.1007/s40273-020-00952-0.
PubMed 32812149Lala A, McNulty SE, Mentz RJ, Dunlay SM, Vader JM, AbouEzzeddine OF, DeVore AD, Khazanie P, Redfield MM, Goldsmith SR, Bart BA, Anstrom KJ, Felker GM, Hernandez AF, Stevenson LW. Relief and Recurrence of Congestion During and After Hospitalization for Acute Heart Failure: Insights From Diuretic Optimization Strategy Evaluation in Acute Decompensated Heart Failure (DOSE-AHF) and Cardiorenal Rescue Study in Acute Decompensated Heart Failure (CARESS-HF). Circ Heart Fail. 2015 Jul;8(4):741-8. doi: 10.1161/CIRCHEARTFAILURE.114.001957. Epub 2015 Jun 3.
PubMed 26041600Maw AM, Lucas BP, Sirovich BE, Soni NJ. Discharge-ready volume status in acute decompensated heart failure: a survey of hospitalists. J Community Hosp Intern Med Perspect. 2020 Jun 14;10(3):199-203. doi: 10.1080/20009666.2020.1759867.
PubMed 32850065Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713.
PubMed 17331245
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Ultrasound-Guided Diuresis for Acute Decompensated Heart Failure to Reduce 30-Day Readmissions and Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06921603
- Acronym / sponsor ID
- POCUSHF-GD / STUDY24090092
- Conditions
- Heart Decompensation, Acute, Acute Kidney Injuries
- Keywords
- heart failure, point-of-care-ultrasound, readmission, acute kidney injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 588 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomized into two groups: a POCUS-assessed group and a standard care control group. Each group follows separate management protocols during the study.
| Arm | Type | Receives |
|---|---|---|
| POCUS-assessed diuretic management | Experimental | Other: POCUS-Assessed Diuretic ManagementParticipants 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. |
| Furosemide (Standard Diuretic) Treatment | Active comparator | Other: Furosemide (Standard Diuretic) TreatmentParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide (Standard Diuretic) TreatmentParticipants 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. | Other | Furosemide (Standard Diuretic) Treatment |
| POCUS-Assessed Diuretic ManagementPOCUS 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. | Other | POCUS-assessed diuretic management |
Primary outcome
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.
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)
4 secondary outcomes
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.
Length of Hospital Stay
Time frame: 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.
Adherence to POCUS-Based Recommendations
Time frame: From date of hospital admission until date of hospital discharge, assessed up to 60 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Background: PubMed 18768945Kim WR, Biggins SW, Kremers WK, Wiesner RH, Kamath PS, Benson JT, Edwards E, Therneau TM. Hyponatremia and mortality among patients on the liver-transplant waiting list. N Engl J Med. 2008 Sep 4;359(10):1018-26. doi: 10.1056/NEJMoa0801209.
- BackgroundAbstract 12544: Point-of-Care Ultrasound Estimation of Right Atrial Pressure Predicts Early Readmission in Patients With Acute Decompensated Heart Failure
- Background: PubMed 33637390Heldeweg MLA, Jagesar AR, Haaksma ME, Smit JM, Paulus F, Schultz MJ, Tuinman PR. Effects of Lung Ultrasonography-Guided Management on Cumulative Fluid Balance and Other Clinical Outcomes: A Systematic Review. Ultrasound Med Biol. 2021 May;47(5):1163-1171. doi: 10.1016/j.ultrasmedbio.2021.01.024. Epub 2021 Feb 23.
- Background: PubMed 38681155Yampolsky S, Kwan A, Cheng S, Kedan I. Point of Care Ultrasound for Diagnosis and Management in Heart Failure: A Targeted Literature Review. POCUS J. 2024 Apr 22;9(1):117-130. doi: 10.24908/pocus.v9i1.16795. eCollection 2024.
- Background: PubMed 34419599Chaudhary R, Sukhi A, Simon MA, Villanueva FS, Pacella JJ. Role of Internal Jugular Venous Ultrasound in suspected or confirmed Heart Failure: A Systematic Review. J Card Fail. 2022 Apr;28(4):639-649. doi: 10.1016/j.cardfail.2021.08.009. Epub 2021 Aug 19.
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- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John J Pacella, MD principal investigator
University of Pittsburgh Medical Center (UPMC)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide (Standard Diuretic) Treatment and POCUS-Assessed Diuretic Management in people with Heart Decompensation, Acute and Acute Kidney Injuries, run by University of Pittsburgh at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John J Pacella, MD (4127805529, pacellajj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06921603, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.