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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.
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: 1. To assess differences in diuretic responsiveness in individuals with varying cardiac dysfunction (i.e., length of stay for patients with HFpEF vs HFrEF) 2. To assess differences in diuretic responsiveness in individuals with varying right ventricular function 3. To assess differences in hospital length of stay between SOC and VExUS-guided decongestion groups 4. To assess differences in 30- and 90-day mortality between SOC and VExUS-guided decongestion groups 5. To assess differences in need for renal replacement therapy between SOC and VExUS-guided decongestion groups
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Boston Medical Center
Boston, Massachusetts, United States
Start Date
April 1, 2026
Primary Completion Date
October 1, 2027
Completion Date
October 1, 2027
Last Updated
March 2, 2026
200
ESTIMATED participants
Five-point ultrasound
DEVICE
Standard of care
OTHER
Lead Sponsor
Boston Medical Center
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04163614