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Boston Medical Center Ultrasound Decongestion Study in Heart Failure

Boston Medical Center Ultrasound Decongestion Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Physical exams, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a five-point ultrasound scan can spot extra fluid in the body and help guide treatment to keep fluid from building up again. It is for patients at Boston Medical Center whose long-term heart failure has worsened and who need treatment to remove extra fluid.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have worsening long-term heart failure and receive fluid-removal treatment in the hospital or at the BMC Heart Failure Infusion Clinic.
  • Be willing and able to have short ultrasound scans of the belly and chest throughout the hospital stay.
  • Have heart failure affecting the right side, left side, or both sides of the heart.

Who can't join

  • Have very low blood pressure for more than 24 hours: a top number below 85 mmHg or an average pressure below 60 mmHg.
  • Had belly surgery in the past month.
  • Have serious liver disease, either recent or long-term.
  • Have end-stage kidney disease treated with dialysis, severe sudden kidney damage, or need treatment that replaces kidney function. Stage V kidney disease with a filtering rate below 15 rules out the kidney vein ultrasound.
  • Have a known blood clot in the large belly vein called the inferior vena cava or the vein carrying blood to the liver.
  • Have sudden heart muscle swelling, sudden heart valve disease, or a type 1 heart attack.
  • Have a health problem that makes a belly ultrasound too painful or uncomfortable.
  • Be unable to give informed consent. Staff will check understanding by asking patients to explain key study details in their own words.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

MA