An interventional study of Five-point ultrasound and Standard of care in Congestive Heart Failure and Volume Overload, sponsored by Boston Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Treatment
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.
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:
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 200 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care.
Device: Five-point ultrasound · Other: Standard of care
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.
Device: Five-point ultrasound · Other: Standard of care
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 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.
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%).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: admission to 4 weeks post discharge (on average 3-10 days)
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.
Time frame: 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
Time frame: 30 days post discharge (on average 3-10 days)
All-cause mortality
All-cause mortality will be abstracted from the participants' electronic medical records.
Time frame: 30 days, 90 days
Need for renal replacement therapy
The need for renal replacement therapy will be abstracted from the participants' electronic medical records.
Time frame: 30 days, 90 days
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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