Boston Medical Center Ultrasound Decongestion Study in Heart Failure

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT07096726
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Five-point ultrasound guided diuresis
    Participants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care.
  • Active Comparator: Standard of care guided diuresis
    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.

Primary Outcome Measure

VExUS Doppler profiles and scores [ Time Frame: At admission, At discharge (on average 3-10 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Deepa M Gopal, MD
[email protected]
617-638-8717
Om Kothari, MD
[email protected]

Find similar trials in Boston, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Boston Medical Center· Boston, MA

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