Boston Medical Center Ultrasound Decongestion Study in Heart Failure

Официальное название

Boston Medical Center Ultrasound Decongestion Study

Обзор

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.

Подробное описание

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

Вмешательства

• Устройство Five-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.
• Другое Standard 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.

Первичные конечные точки

• VExUS Doppler profiles and scores [Срок оценки: At admission, At discharge (on average 3-10 days)]
• 30-day hospital readmission rate [Срок оценки: 30 days after discharge (on average 3-10 days)]
• 90-day hospital readmission rate [Срок оценки: 90 days after discharge (on average 3-10 days)]
• Worsening renal failure/acute renal injury [Срок оценки: admission to 4 weeks post discharge (on average 3-10 days)]

Вторичные конечные точки (4)

• Hospital length-of-stay for decompensated heart failure [Срок оценки: At hospital discharge (on average 3-10 days)]
• 30-day HF readmission rate [Срок оценки: 30 days post discharge (on average 3-10 days)]
• All-cause mortality [Срок оценки: 30 days, 90 days]
• Need for renal replacement therapy [Срок оценки: 30 days, 90 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Boston Medical Center — Boston

Идентификаторы

NCT: NCT07096726 · H-44593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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