Heart Failure Clinical Trial
— BLUSHED-AHFOfficial title:
B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial
Verified date | June 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | June 20, 2019 |
Est. primary completion date | March 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University | Cleveland | Ohio |
United States | Detroit Receiving Hospital | Detroit | Michigan |
United States | INOVA Health System | Fairfax | Virginia |
United States | Eskenazi Health | Indianapolis | Indiana |
United States | IU Health Methodist Hospital | Indianapolis | Indiana |
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Indiana University | Case Western Reserve University, Inova Fairfax Hospital, Vanderbilt University, Wayne State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total Days Alive and Out Of Hospital (DAOOH) | Total days alive and out of hospital through 30 and 90 days post-discharge | Up through 90 days, with specific reporting of events through 30 and 90 days | |
Other | Association of B-lines at Discharge and 30-day / 90-day Outcomes | Up through 90 days, with specific reporting of events through 30 and 90 days | ||
Other | Change in Biomarkers From Presentation to Pre-discharge | From admission to pre-discharge from the hospital, on average 5 to 7 days. | ||
Other | Time to Reach B-lines <15 | Throughout hospitalization, on average 5-7 days | ||
Other | B Lines < 15 at 24 Hours and at Discharge | Through the first 24 hours and then prior to discharge, on average 5-7 days after admission | ||
Other | Composite of 30-day and 90-day All-cause Mortality, Cardiovascular (CV) Re-hospitalizations, and CV Emergency Department (ED) Revisits. | CV endpoints are defined according to the 2014 American College of Cardiology/American Heart Association (ACC/AHA) Key Data Elements and Definitions for Cardiovascular Endpoint Events. | Up through 90 days, with specific reporting of events through 30 and 90 days | |
Other | All Cause Readmissions, All Cause ED Re-visits | 30- day and 90-day | Up through 90 days, with specific reporting of events through 30 and 90 days | |
Other | Number of Participants With Physical Exam Findings of Heart Failure When Discharge is Compared to Baseline | Physical exam includes body weight, peripheral edema, jugular venous distention, pulmonary and cardiac auscultation | From admission throughout hospitalization, usually 5-7 days. | |
Other | Count of Pharmacologic Therapies the Patient Received in the ED | This is a description of which pharmacologic therapies the patient has received. | From admission throughout hospitalization, usually 5-7 days. | |
Other | Count of Pharmacologic and Device Therapies the Patient Received During Hospitalization | This is a description of which pharmacologic and device therapies the patient has received. | From admission throughout hospitalization, usually 5-7 days. | |
Other | Comparison of LUS Interpretation Within and Between Trained Investigators as Well as the Core Lab | Calculation of intra and inter-agreement between investigators and also the Core Lab to determine the reproducibility of LUS | From admission throughout hospitalization, usually 5-7 days. | |
Other | Association of Baseline, Discharge, and Change With 30 and 90 Day Outcomes | Up through 90 days, with specific reporting of events through 30 and 90 days | ||
Primary | Number of Participants With B-lines = 15 at the Conclusion of ED AHF Management | B-lines = 15 at the conclusion of ED AHF management or maximum of 6 hours after enrollment, whichever comes first. | During the ED phase of management, usually no more than 6 hours |
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