B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial
Condition: Heart Failure; Heart Failure Acute; Acute Cardiac Pulmonary Edema; Acute Cardiac Failure
MeSH terms: Pulmonary Edema; Heart Failure
Intervention: LUS-guided strategy-of-care; Usual Care; Intravenous Loop Diuretic; Vasodilator; Non invasive Ventilation (NIV)
Intervention description: For patients randomized to the strategy-of-care arm, the LUS guided protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.
Treatment protocol:
IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive.
Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV)
Reassessment every 2 hours; Patients will receive usual AHF care; IV loop diuretic; IV, topical, or SL Vasodilator; Face, mouth, or nasal mask applied to provide positive pressure ventilation
Intervention MeSH terms: Vasodilator Agents; Diuretics; Sodium Potassium Chloride Symporter Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Masking description: A central, independent, Core Lab will review all images.
Enrollment: 130.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Heart Failure; Acute Heart Failure; Pulmonary Edema; Lung ultrasound; Extra vascular lung water; B-lines

Summary:

      Nearly 80% of acute heart failure (AHF) patients admitted to the hospital are initially
      treated in the emergency department (ED). Once admitted, within 30 days post-discharge, 27%
      of patients are re-hospitalized or die. Attempts to improve outcomes with novel therapies
      have all failed. The evidence for existing AHF therapies are poor: No currently used AHF
      treatment is known to improve outcomes. ED treatment is largely the same today as 40 years
      ago. Congestion, such as difficulty breathing, weight gain, and leg swelling, is the primary
      reason why patients present to the hospital for AHF. Treating congestion is the cornerstone
      of AHF management. Yet half of all AHF patients leave the hospital inadequately decongested.
      The investigators propose a novel approach to aggressively decongest patients in the ED
      setting: lung ultrasound guided, protocol driven, AHF management. LUS B-lines are a measure
      of extra-vascular lung water (EVLW). In the setting of AHF, LUS B-lines are a measure of
      congestion. This simple, easily learned technique has excellent reliability and
      reproducibility. The investigators hypothesize that a strategy-of-care will outperform usual
      care. At the present time, usual care is largely empirical. This study will improve the
      evidence base for ED AHF management. This proposed pilot study, if successful, will lead to
      an outcome trial examining whether an ED AHF strategy-of-care increases days alive and out of
      the hospital for patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 21 years

          -  Presents with shortness of breath at rest or with minimal exertion

          -  Clinical diagnosis of AHF and presence of > 15 total bilateral B-lines distributed in
             at least 4 zones on initial LUS

          -  Hx of chronic HF and any one of the following:

               -  Chest radiograph consistent with AHF

               -  Jugular venous distension

               -  Pulmonary rales on auscultation

               -  Lower extremity edema

        Exclusion Criteria:

          -  Chronic renal dysfunction, including end-stage renal disease (ESRD) or estimated
             glomerular filtration rate (eGFR) < 45ml//min/1.73m2.

          -  Shock of any kind. Any requirement for vasopressors or inotropes.

          -  Systolic blood pressure (SBP) < 100 or >175 mmHg

          -  Need for immediate intubation

          -  Acute Coronary Syndrome- Presentation consistent with myocardial ischemia AND either
             new ST-segment elevation/depression

          -  Fever >101.5 ºF or chest radiograph or clinical picture of pneumonia

          -  End stage HF: transplant list, ventricular assist device

          -  Anemia requiring transfusion

          -  Known interstitial lung disease

          -  Suspected acute lung injury or acute respiratory distress syndrome (ARDS)

          -  Pregnant or recently pregnant within the last 6 months