Boston Medical Center Ultrasound Decongestion Study in Heart Failure (BUDS-HF)

Boston Medical Center (BMC)

Status: Not yet enrolling

Conditions: Volume Overload; Congestive Heart Failure

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07096726

H-44593

Details and patient eligibility

About

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.

Full description

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Five-point ultrasound guided diuresis

Experimental group

Description:

Participants randomized to this study arm will have their diuresis guided by five-point ultrasound to assess venous congestion and receive standard of care.

Treatment:

Other: Standard of care

Device: Five-point ultrasound

Standard of care guided diuresis

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care

Device: Five-point ultrasound