Congestive Heart FailureBUDS-HFNCT07096726
Boston Medical Center Ultrasound Decongestion Study in Heart Failure
A study testing Five-point ultrasound in people with Congestive Heart Failure and Volume Overload, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to analyze the utility of a novel five-point ultrasound as a predictor of volume overload in diverse patients who are admitted with volume overload/congestive heart failure (CHF) exacerbation at Boston Medical Center (BMC), the largest safety-net hospital in New England. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Volume Overload
- What is being tested?
- Five-point ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2027
- 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
Who may be able to join
- Patient with a primary diagnosis of acute on chronic decompensated heart failure who is admitted to inpatient or presents to the outpatient Boston Medical Center (BMC) Heart Failure Infusion clinic for decongestion treatment.
- Willing and able to receive short abdominal and thoracic ultrasounds throughout hospitalization
- Patients with right and/or left ventricular failure
Who cannot join
- Hemodynamic instability defined as systolic blood pressure <85 mmHg or mean arterial pressure <60 mm Hg for greater than 24 hours duration
- Abdominal surgery in the past 1 month
- Significant acute or chronic liver disease
- End stage renal disease on dialysis
- Advanced chronic kidney disease (CKD) [Stage V CKD with glomerular filtration rate (GFR) <15] to exclude renal vein doppler ultrasound
- Severe acute kidney injury (AKI) or requiring renal replacement therapy
Show all 12Show fewer
- Known abdominal thrombus in the inferior vena cava (IVC) or portal vein
- Acute myocarditis
- Acute valvular disease
- Acute type 1 myocardial infarction
- Medical condition precluding abdominal ultrasound due to significant discomfort or pain
- Adults not able to provide consent (a simple teach back method of key aspects discussed in consent form will be utilized to verify if patient is able to adequately provide informed consent)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Om Kothari, MD contact
United States1 site
Boston Medical Center
Boston, Massachusetts, 02118
Deepa M Gopal, MD, 617-638-8717, dmgopal@bu.edu
Om Kothari, MD, Om.Kothari@bmc.org
About this study
Official title: Boston Medical Center Ultrasound Decongestion Study
The purpose of this study is to analyze the utility of a novel five-point ultrasound as a predictor of volume overload in diverse patients who are admitted with volume overload/congestive heart failure (CHF) exacerbation at Boston Medical Center (BMC), the largest safety-net hospital in New England. Current standard of care (SOC) involves the utilization of laboratory markers and physical exam, which is often inconsistent and equivocal. The investigators will assess will assess if ultrasound-assisted diuresis reduces recurrent episodes of volume overload/decompensated heart failure.
Read the detailed description
This superiority randomized clinical trial will compare the therapeutic intervention of five-point ultrasound-guided diuresis with standard of care diuresis for decompensated heart failure. Participants with heart failure exacerbation will be randomly allocated in a 1:1 ratio using heart failure patient lists, by a heart failure physician in the emergency department or on the floors. Similarly, patients will be randomly selected in a 1:1 ratio in the outpatient heart failure infusion clinic when seen for heart failure exacerbation by a heart failure physician. The study population will be generally stable and can be inpatient or outpatient.
The primary objective of the study is to evaluate and compare the efficacy of diuresis when driven by standard of care or five-point ultrasound to guide clinical decision making by assessing 30-day hospital readmission rate in patients undergoing standard of care vs ultrasound assisted diuresis.
The specific aims are:
Aim 1. To measure and compare changes in ultrasonographic parameters (ultrasound Doppler profiles, VExUS scores) through the course of a HF hospitalization for decongestion for acute decompensated HF admission.
Aim 2. To compare 30-day and 90-day HF readmission rates between randomized patients with HF admission comparing SOC to VExUS-guided decongestion strategy.
Aim 3: To compare worsening renal failure/acute renal injury (defined as 25% increase in serum Cr/cystatin C from time of admission to 4 weeks post-discharge) between randomized admitted HF patients comparing SOC to VExUS-guided decongestion strategy.
Secondary objectives include:
- To assess differences in diuretic responsiveness in individuals with varying cardiac dysfunction (i.e., length of stay for patients with HFpEF vs HFrEF)
- To assess differences in diuretic responsiveness in individuals with varying right ventricular function
- To assess differences in hospital length of stay between SOC and VExUS-guided decongestion groups
- To assess differences in 30- and 90-day mortality between SOC and VExUS-guided decongestion groups
- To assess differences in need for renal replacement therapy between SOC and VExUS-guided decongestion groups
- Conditions
- Congestive Heart Failure, Volume Overload
- Being tested
- Five-point ultrasound, Standard of care
- Keywords
- Venous Excess Ultrasound (VExUS), Ultrasound-assisted diuresis, Heart Failure with Preserved Ejection Fraction (HFpEF), Heart Failure with Reduced Ejection Fraction (HFrEF)
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Five-point ultrasoundDevice
In-person study visits will be done on initial evaluation and then at least every 48 hours, during which serial five-point ultrasound will be performed to assess venous congestion. Each visit will not be at strict intervals; a reasonable time window is every 48 hours +/- 12 hours. Ultrasound may be performed more frequently if clinically indicated. During these visits or between them, ultrasound of the heart may additionally be performed. Each visit will last between 10 and 60 minutes.
Standard of careOther
Standard of care will most likely include radiographic investigations (chest X-ray, chest CT), laboratory evaluation (complete blood counts, metabolic panel, B-type natriuretic peptide, high-sensitivity troponin, electrolytes, renal function, urine testing), volume status, and cardiopulmonary physical exam.
| Study group | Role | What they receive |
|---|---|---|
| Five-point ultrasound guided diuresis | Experimental | Participants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care. Receives: Device: Five-point ultrasound; Other: Standard of care |
| Standard of care guided diuresis | Active comparator | Participants randomized to this study arm will have their diuresis clinically guided by standard of care. They will also have five point ultrasound but the results will not inform their diuresis. Receives: Device: Five-point ultrasound; Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
VExUS Doppler profiles and scores
The range of VExUS profiles and scores to guide clinicians with heart failure diuresis are: No congestion (normal inferior vena cava), Minimal congestion (0 or 1 abnormal doppler patterns). Mild congestion (2 abnormal patterns and portal vein pulsatility fraction [PVPF] less than 30%), Moderate congestion (2 abnormal patterns and PVPF between 30 and 50%), Severe congestion (2 abnormal patterns and PVPF more than 50%).
Measured: At admission, At discharge (on average 3-10 days)
30-day hospital readmission rate
The number of any hospital readmissions within 30 days of discharge will be abstracted from the participants' electronic medical records.
Measured: 30 days after discharge (on average 3-10 days)
90-day hospital readmission rate
The number of any hospital readmissions within 90 days of discharge will be abstracted from the participants' electronic medical records.
Measured: 90 days after discharge (on average 3-10 days)
Worsening renal failure/acute renal injury
This outcome is defined by an increase in 25% of serum creatinine or serum cystatin C from the time of admission to 4 weeks post discharge. It will be abstracted from the participants' electronic medical records.
Measured: admission to 4 weeks post discharge (on average 3-10 days)
Secondary outcomes (4)
Hospital length-of-stay for decompensated heart failure
The total number of days hospitalized for decompensated heart failure will be abstracted from the participants' electronic medical records.
Measured: At hospital discharge (on average 3-10 days)
30-day HF readmission rate
The number of readmissions within 30-days of hospital discharge that are specifically due to HF
Measured: 30 days post discharge (on average 3-10 days)
All-cause mortality
All-cause mortality will be abstracted from the participants' electronic medical records.
Measured: 30 days, 90 days
Need for renal replacement therapy
The need for renal replacement therapy will be abstracted from the participants' electronic medical records.
Measured: 30 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in the emergency department, on the floors, or in the outpatient heart failure infusion clinic will be randomly allocated in a 1:1 ratio to the study arms.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deepa M Gopal, MD, Principal investigator, Boston Medical Center, Cardiovascular Medicine/Heart FailureAala Jaberi, MD, Principal investigator, Boston Medical Center, Nephrology Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096726
- Sponsor's protocol ID
- H-44593
- Acronym
- BUDS-HF
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boston Medical Center Ultrasound Decongestion Study
- ClinicalTrials.gov ID
- NCT07096726
- Acronym / sponsor ID
- BUDS-HF / H-44593
- Conditions
- Congestive Heart Failure, Volume Overload
- Keywords
- Venous Excess Ultrasound (VExUS), Ultrasound-assisted diuresis, Heart Failure with Preserved Ejection Fraction (HFpEF), Heart Failure with Reduced Ejection Fraction (HFrEF)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jul 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.
The purpose of this study is to analyze the utility of a novel five-point ultrasound as a predictor of volume overload in diverse patients who are admitted with volume overload/congestive heart failure (CHF) exacerbation at Boston Medical Center (BMC), the largest safety-net hospital in New England. Current standard of care (SOC) involves the utilization of laboratory markers and physical exam, which is often inconsistent and equivocal. The investigators will assess will assess if ultrasound-assisted diuresis reduces recurrent episodes of volume overload/decompensated heart failure.
Detailed description
This superiority randomized clinical trial will compare the therapeutic intervention of five-point ultrasound-guided diuresis with standard of care diuresis for decompensated heart failure. Participants with heart failure exacerbation will be randomly allocated in a 1:1 ratio using heart failure patient lists, by a heart failure physician in the emergency department or on the floors. Similarly, patients will be randomly selected in a 1:1 ratio in the outpatient heart failure infusion clinic when seen for heart failure exacerbation by a heart failure physician. The study population will be generally stable and can be inpatient or outpatient.
The primary objective of the study is to evaluate and compare the efficacy of diuresis when driven by standard of care or five-point ultrasound to guide clinical decision making by assessing 30-day hospital readmission rate in patients undergoing standard of care vs ultrasound assisted diuresis.
The specific aims are:
Aim 1. To measure and compare changes in ultrasonographic parameters (ultrasound Doppler profiles, VExUS scores) through the course of a HF hospitalization for decongestion for acute decompensated HF admission.
Aim 2. To compare 30-day and 90-day HF readmission rates between randomized patients with HF admission comparing SOC to VExUS-guided decongestion strategy.
Aim 3: To compare worsening renal failure/acute renal injury (defined as 25% increase in serum Cr/cystatin C from time of admission to 4 weeks post-discharge) between randomized admitted HF patients comparing SOC to VExUS-guided decongestion strategy.
Secondary objectives include:
- To assess differences in diuretic responsiveness in individuals with varying cardiac dysfunction (i.e., length of stay for patients with HFpEF vs HFrEF)
- To assess differences in diuretic responsiveness in individuals with varying right ventricular function
- To assess differences in hospital length of stay between SOC and VExUS-guided decongestion groups
- To assess differences in 30- and 90-day mortality between SOC and VExUS-guided decongestion groups
- To assess differences in need for renal replacement therapy between SOC and VExUS-guided decongestion groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants in the emergency department, on the floors, or in the outpatient heart failure infusion clinic will be randomly allocated in a 1:1 ratio to the study arms.
| Arm | Type | Receives |
|---|---|---|
| Five-point ultrasound guided diuresis | Experimental | Device: Five-point ultrasound, Other: Standard of careParticipants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care. |
| Standard of care guided diuresis | Active comparator | Device: Five-point ultrasound, Other: Standard of careParticipants randomized to this study arm will have their diuresis clinically guided by standard of care. They will also have five point ultrasound but the results will not inform their diuresis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with a primary diagnosis of acute on chronic decompensated heart failure who is admitted to inpatient or presents to the outpatient Boston Medical Center (BMC) Heart Failure Infusion clinic for decongestion treatment.
- Willing and able to receive short abdominal and thoracic ultrasounds throughout hospitalization
- Patients with right and/or left ventricular failure
Key exclusion criteria (12 listed)
- Hemodynamic instability defined as systolic blood pressure <85 mmHg or mean arterial pressure <60 mm Hg for greater than 24 hours duration
- Abdominal surgery in the past 1 month
- Significant acute or chronic liver disease
- End stage renal disease on dialysis
- Advanced chronic kidney disease (CKD) [Stage V CKD with glomerular filtration rate (GFR) <15] to exclude renal vein doppler ultrasound
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 |
|---|---|---|
| Five-point ultrasoundIn-person study visits will be done on initial evaluation and then at least every 48 hours, during which serial five-point ultrasound will be performed to assess venous congestion. Each visit will not be at strict intervals; a reasonable time window is every 48 hours +/- 12 hours. Ultrasound may be performed more frequently if clinically indicated. During these visits or between them, ultrasound of the heart may additionally be performed. Each visit will last between 10 and 60 minutes. | Device | Five-point ultrasound guided diuresis, Standard of care guided diuresis |
| Standard of careStandard of care will most likely include radiographic investigations (chest X-ray, chest CT), laboratory evaluation (complete blood counts, metabolic panel, B-type natriuretic peptide, high-sensitivity troponin, electrolytes, renal function, urine testing), volume status, and cardiopulmonary physical exam. | Other | Five-point ultrasound guided diuresis, Standard of care guided diuresis |
Primary outcome
VExUS Doppler profiles and scores
Time frame: At admission, At discharge (on average 3-10 days)
The range of VExUS profiles and scores to guide clinicians with heart failure diuresis are: No congestion (normal inferior vena cava), Minimal congestion (0 or 1 abnormal doppler patterns). Mild congestion (2 abnormal patterns and portal vein pulsatility fraction [PVPF] less than 30%), Moderate congestion (2 abnormal patterns and PVPF between 30 and 50%), Severe congestion (2 abnormal patterns and PVPF more than 50%).
30-day hospital readmission rate
Time frame: 30 days after discharge (on average 3-10 days)
The number of any hospital readmissions within 30 days of discharge will be abstracted from the participants' electronic medical records.
90-day hospital readmission rate
Time frame: 90 days after discharge (on average 3-10 days)
The number of any hospital readmissions within 90 days of discharge will be abstracted from the participants' electronic medical records.
Worsening renal failure/acute renal injury
Time frame: admission to 4 weeks post discharge (on average 3-10 days)
This outcome is defined by an increase in 25% of serum creatinine or serum cystatin C from the time of admission to 4 weeks post discharge. It will be abstracted from the participants' electronic medical records.
4 secondary outcomes
Hospital length-of-stay for decompensated heart failure
Time frame: At hospital discharge (on average 3-10 days)
30-day HF readmission rate
Time frame: 30 days post discharge (on average 3-10 days)
All-cause mortality
Time frame: 30 days, 90 days
Need for renal replacement therapy
Time frame: 30 days, 90 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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Om Kothari, MD contact
Deepa M Gopal, MD principal investigator
Boston Medical Center, Cardiovascular Medicine/Heart Failure
Aala Jaberi, MD principal investigator
Boston Medical Center, Nephrology Section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Five-point ultrasound in people with Congestive Heart Failure and Volume Overload, run by Boston Medical Center at 1 site 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?
The sponsor lists 3 inclusion and 12 exclusion criteria. 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Deepa M Gopal, MD (617 638 8717, dmgopal@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VExUS Doppler profiles and scores (time frame: At admission, At discharge (on average 3-10 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.