Boston Medical Center Ultrasound Decongestion Study in Heart Failure

NCT07096726 | Not Yet Recruiting FDA Device

• 1 other identifier: H-44593
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

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)

Outcome Measures

Primary Outcomes (4)

• 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%).

  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.

  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.

  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.

  admission to 4 weeks post discharge (on average 3-10 days)

Secondary Outcomes (4)

• Hospital length-of-stay for decompensated heart failure

  At hospital discharge (on average 3-10 days)

• 30-day HF readmission rate

  30 days post discharge (on average 3-10 days)

• All-cause mortality

  30 days, 90 days

• Need for renal replacement therapy

  30 days, 90 days

Study Arms (2)

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.

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.

Device: Five-point ultrasound; Other: Standard of care

Interventions

Five-point ultrasound DEVICE

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.

Five-point ultrasound guided diuresis; Standard of care guided diuresis

Standard of care OTHER

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.

Five-point ultrasound guided diuresis; Standard of care guided diuresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Heart Failure; Edema

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Deepa M Gopal, MD

  Boston Medical Center, Cardiovascular Medicine/Heart Failure

  PRINCIPAL INVESTIGATOR

• Aala Jaberi, MD

  Boston Medical Center, Nephrology Section

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deepa M Gopal, MD

CONTACT

617 638 8717; dmgopal@bu.edu

Om Kothari, MD

CONTACT

om.kothari@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants in both arms will be blinded as they will receive VExUS scan throughout their admission. For the control arm, the treatment team (clinicians) will be blinded to the VExUS scores and will conduct SOC with the patient for the course of their admission. All investigator sonographers performing the VExUS scans will be blinded to arm assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)