Congestive Heart Failure, Volume Overload
Conditions
Keywords
Venous Excess Ultrasound (VExUS), Ultrasound-assisted diuresis, Heart Failure with Preserved Ejection Fraction (HFpEF), Heart Failure with Reduced Ejection Fraction (HFrEF)
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.
Detailed 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
Interventions
DEVICEFive-point ultrasound
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.
OTHERStandard of care
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.
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VExUS Doppler profiles and scores | At admission, At discharge (on average 3-10 days) | 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%). |
| 30-day hospital readmission rate | 30 days after discharge (on average 3-10 days) | The number of any hospital readmissions within 30 days of discharge will be abstracted from the participants' electronic medical records. |
| 90-day hospital readmission rate | 90 days after discharge (on average 3-10 days) | The number of any hospital readmissions within 90 days of discharge will be abstracted from the participants' electronic medical records. |
| Worsening renal failure/acute renal injury | admission to 4 weeks post discharge (on average 3-10 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length-of-stay for decompensated heart failure | At hospital discharge (on average 3-10 days) | The total number of days hospitalized for decompensated heart failure will be abstracted from the participants' electronic medical records. |
| 30-day HF readmission rate | 30 days post discharge (on average 3-10 days) | The number of readmissions within 30-days of hospital discharge that are specifically due to HF |
| All-cause mortality | 30 days, 90 days | All-cause mortality will be abstracted from the participants' electronic medical records. |
| Need for renal replacement therapy | 30 days, 90 days | The need for renal replacement therapy will be abstracted from the participants' electronic medical records. |
Countries
United States
Contacts
CONTACTDeepa M Gopal, MD
CONTACTOm Kothari, MD
PRINCIPAL_INVESTIGATORDeepa M Gopal, MD
Boston Medical Center, Cardiovascular Medicine/Heart Failure
PRINCIPAL_INVESTIGATORAala Jaberi, MD
Boston Medical Center, Nephrology Section
Outcome results
None listed