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

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

Interventions

OTHER

LUS-guided strategy-of-care

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

OTHER

Usual Care

Patients will receive usual AHF care

DRUG

Intravenous Loop Diuretic

IV loop diuretic

DRUG

Vasodilator

IV, topical, or SL Vasodilator

DEVICE

Non invasive Ventilation (NIV)

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

Sponsors & Collaborators

• Inova Fairfax Hospital

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• Wayne State University

  collaborator OTHER

• Indiana University

  lead OTHER

Principal Investigators

• Peter S Pang, MD · Indiana University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-10

Primary Completion

2019-03-20

Completion

2019-06-20

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations