Boston Medical Center Ultrasound Decongestion Study in Heart Failure (NCT07096726) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Boston Medical Center Ultrasound Decongestion Study in Heart Failure
United States200 participantsStarted 2026-06
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
VExUS Doppler profiles and scores
Timeframe: At admission, At discharge (on average 3-10 days)
2
30-day hospital readmission rate
Timeframe: 30 days after discharge (on average 3-10 days)
3
90-day hospital readmission rate
Timeframe: 90 days after discharge (on average 3-10 days)
4
Worsening renal failure/acute renal injury
Timeframe: admission to 4 weeks post discharge (on average 3-10 days)