B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial

NCT03136198 | Completed Phase 2 Results DMC FDA Drug FDA Device

• 1 other identifier: 1R34HL136986-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Heart Failure; Heart Failure Acute; Acute Cardiac Pulmonary Edema; Acute Cardiac Failure

Keywords

Heart Failure; Acute Heart Failure; Pulmonary Edema; Lung ultrasound; Extra vascular lung water; B-lines

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (12)

• Total Days Alive and Out Of Hospital (DAOOH)

  Up through 90 days, with specific reporting of events through 30 and 90 days

• 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

• Change in Biomarkers From Presentation to Pre-discharge

  From admission to pre-discharge from the hospital, on average 5 to 7 days.

Study Arms (2)

LUS-guided strategy-of-care

EXPERIMENTAL

Patients randomized to the LUS strategy of care arm will be treated according to protocol. This protocol only involves therapies used in everyday AHF clinical practice.

Other: LUS-guided strategy-of-care; Drug: Intravenous Loop Diuretic; Drug: Vasodilator; Device: Non invasive Ventilation (NIV)

Usual care

PLACEBO COMPARATOR

Patients randomized to the usual care arm will also undergo lung ultrasound assessments. However, these results will not be revealed to the care team. Patients will receive treatment per usual, standard care.

Other: Usual Care; Drug: Intravenous Loop Diuretic; Drug: Vasodilator; Device: Non invasive Ventilation (NIV)

Interventions

LUS-guided strategy-of-care OTHER

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: 1. IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive. 2. Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV) 3. Reassessment every 2 hours

LUS-guided strategy-of-care

Usual Care OTHER

Patients will receive usual AHF care

Usual care

Intravenous Loop Diuretic DRUG

IV loop diuretic

LUS-guided strategy-of-care; Usual care

Vasodilator DRUG

IV, topical, or SL Vasodilator

LUS-guided strategy-of-care; Usual care

Non invasive Ventilation (NIV) DEVICE

Face, mouth, or nasal mask applied to provide positive pressure ventilation

LUS-guided strategy-of-care; Usual care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Inova Fairfax Hospital: collaborator
• Vanderbilt University: collaborator
• Case Western Reserve University: collaborator
• Wayne State University: collaborator

Study Sites (6)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

Location

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

INOVA Health System

Fairfax, Virginia, 22042, United States

Location

Related Publications (2)

• Pang PS, Russell FM, Ehrman R, Ferre R, Gargani L, Levy PD, Noble V, Lane KA, Li X, Collins SP. Lung Ultrasound-Guided Emergency Department Management of Acute Heart Failure (BLUSHED-AHF): A Randomized Controlled Pilot Trial. JACC Heart Fail. 2021 Sep;9(9):638-648. doi: 10.1016/j.jchf.2021.05.008. Epub 2021 Jul 7.

  PMID: 34246609 DERIVED

• Russell FM, Ehrman RR, Ferre R, Gargani L, Noble V, Rupp J, Collins SP, Hunter B, Lane KA, Levy P, Li X, O'Connor C, Pang PS. Design and rationale of the B-lines lung ultrasound guided emergency department management of acute heart failure (BLUSHED-AHF) pilot trial. Heart Lung. 2019 May-Jun;48(3):186-192. doi: 10.1016/j.hrtlng.2018.10.027. Epub 2018 Nov 15.

  PMID: 30448355 DERIVED

MeSH Terms

Conditions

Heart Failure; Pulmonary Edema

Interventions

Vasodilator Agents; Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Peter S. Pang
• Organization: Indiana University

ppang@iu.edu

317-880-3900

Study Officials

• Peter S Pang, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: A central, independent, Core Lab will review all images.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: May 2, 2017
• Study Start: July 10, 2017
• Primary Completion: March 20, 2019
• Study Completion: June 20, 2019
• Last Updated: June 4, 2024
• Results First Posted: May 20, 2020

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)