B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 11/22/2018 |
| Start Date: | July 10, 2017 |
| End Date: | September 30, 2019 |
| Contact: | Peter S Pang, MD |
| Email: | ppang@iu.edu |
| Phone: | 317-880-3900 |
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.
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.
The primary goal of the BLUSHED AHF pilot trial is to determine whether an early lung
ultrasound (LUS) guided, protocol-driven ED AHF strategy-of-care leads to more rapid and
sustained resolution of congestion, as measured by LUS B-lines. If the investigators are able
to demonstrate this necessary and sufficient information - targeted strategy-of-care is more
effective than usual care - they will apply for a follow on study to achieve the following
aim.
Aim 1: To demonstrate the effectiveness of a targeted decongestion strategy - LUS guided,
protocol-driven ED AHF management - will result in improved 30-day outcomes vs. usual care.
This aim will be tested using a randomized, controlled, unblinded, pragmatic, multi-center,
simple trial design.
The pilot trial may determine that ED management alone is insufficient to impact the outcome.
Thus, the investigators may need to modify their subsequent trial design to include targeted
therapy throughout hospitalization. However, the pilot study will demonstrate whether
targeted therapy effectively reduces B-lines.
PUBLIC HEALTH IMPACT Over one million hospitalizations for AHF occur every year in the US.
Within 30 days after hospitalization, over 25% of AHF patients will be dead or
re-hospitalized.4 Up to 67% of patients will be re-hospitalized and 36% will be dead by one
year. For patients aged 65 years and older, AHF is the most common and most expensive reason
for hospitalization. Despite major reductions in morbidity and mortality for chronic HF,
considerably less progress has been seen in AHF.
Congestion is the primary reason why AHF patients present to the ED seeking medical care.
Congestion is manifest by signs and symptoms of heart failure (HF); dyspnea, orthopnea,
edema, and weight gain. Yet, how to best assess, grade, and manage congestion is not well
established.
Freedom from congestion is associated with improved outcomes; Yet many patients leave the
hospital inadequately decongested. The absence of robust, reliable methods to assess
congestion is a primary reason why it is not well-assessed. A recent consensus statement
published in 2010 highlights this fact: "…no method to assess congestion…has been validated."
The investigators would argue many ED AHF patients are poorly assessed prior to treatment. In
addition, they are poorly re-assessed prior to hospitalization to gauge the success or
failure of initial management. While physical exam is currently the cornerstone of congestion
assessment, it lacks sensitivity and inter-rater reliability.
The investigators challenge the current paradigm of relying on insensitive methods of
congestion to guide therapy. Furthermore, they argue the lack of a robust evidence base for
ED management of congestion contributes to poor outcomes.
ultrasound (LUS) guided, protocol-driven ED AHF strategy-of-care leads to more rapid and
sustained resolution of congestion, as measured by LUS B-lines. If the investigators are able
to demonstrate this necessary and sufficient information - targeted strategy-of-care is more
effective than usual care - they will apply for a follow on study to achieve the following
aim.
Aim 1: To demonstrate the effectiveness of a targeted decongestion strategy - LUS guided,
protocol-driven ED AHF management - will result in improved 30-day outcomes vs. usual care.
This aim will be tested using a randomized, controlled, unblinded, pragmatic, multi-center,
simple trial design.
The pilot trial may determine that ED management alone is insufficient to impact the outcome.
Thus, the investigators may need to modify their subsequent trial design to include targeted
therapy throughout hospitalization. However, the pilot study will demonstrate whether
targeted therapy effectively reduces B-lines.
PUBLIC HEALTH IMPACT Over one million hospitalizations for AHF occur every year in the US.
Within 30 days after hospitalization, over 25% of AHF patients will be dead or
re-hospitalized.4 Up to 67% of patients will be re-hospitalized and 36% will be dead by one
year. For patients aged 65 years and older, AHF is the most common and most expensive reason
for hospitalization. Despite major reductions in morbidity and mortality for chronic HF,
considerably less progress has been seen in AHF.
Congestion is the primary reason why AHF patients present to the ED seeking medical care.
Congestion is manifest by signs and symptoms of heart failure (HF); dyspnea, orthopnea,
edema, and weight gain. Yet, how to best assess, grade, and manage congestion is not well
established.
Freedom from congestion is associated with improved outcomes; Yet many patients leave the
hospital inadequately decongested. The absence of robust, reliable methods to assess
congestion is a primary reason why it is not well-assessed. A recent consensus statement
published in 2010 highlights this fact: "…no method to assess congestion…has been validated."
The investigators would argue many ED AHF patients are poorly assessed prior to treatment. In
addition, they are poorly re-assessed prior to hospitalization to gauge the success or
failure of initial management. While physical exam is currently the cornerstone of congestion
assessment, it lacks sensitivity and inter-rater reliability.
The investigators challenge the current paradigm of relying on insensitive methods of
congestion to guide therapy. Furthermore, they argue the lack of a robust evidence base for
ED management of congestion contributes to poor outcomes.
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 ESRD or eGFR < 45ml//min/1.73m2.
- Shock of any kind. Any requirement for vasopressors or inotropes.
- SBP < 100 or >175mmHg
- Need for immediate intubation
- Acute Coronary Syndrome- Presentation consistent with myocardial ischemia AND either
new ST-segment elevation/depression
- Fever >101.5ºF 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
We found this trial at
6
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Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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