Trial Outcomes & Findings for B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial (NCT NCT03136198)
NCT ID: NCT03136198
Last Updated: 2024-06-04
Results Overview
B-lines ≤ 15 at the conclusion of ED AHF management or maximum of 6 hours after enrollment, whichever comes first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
During the ED phase of management, usually no more than 6 hours
Results posted on
2024-06-04
Participant Flow
Participant milestones
| Measure |
LUS-guided Strategy-of-care
Patients randomized to the lung ultrasound (LUS) strategy of care arm will be treated according to protocol. This protocol only involves therapies used in everyday AHF clinical practice.
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
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
Usual Care
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.
Usual Care: Patients will receive usual AHF care
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
64
|
|
Overall Study
COMPLETED
|
66
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
B-lines Lung Ultrasound Guided ED Management of Acute Heart Failure Pilot Trial
Baseline characteristics by cohort
| Measure |
LUS-guided Strategy-of-care
n=66 Participants
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.
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
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
Usual Care
n=64 Participants
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.
Usual Care: Patients will receive usual AHF care
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
65.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
64 participants
n=7 Participants
|
130 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the ED phase of management, usually no more than 6 hoursPopulation: Out of the 130 participants a total of 8 (5 in the LUS-guided strategy of care arm and 3 in the Usual care arm) had a recorded ED discharge time which was prior to the first LUS, leaving 61 participants in each arm to be analyzed for the primary outcome.
B-lines ≤ 15 at the conclusion of ED AHF management or maximum of 6 hours after enrollment, whichever comes first.
Outcome measures
| Measure |
LUS-guided Strategy-of-care
n=61 Participants
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.
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
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
Usual Care
n=61 Participants
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.
Usual Care: Patients will receive usual AHF care
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
|---|---|---|
|
Number of Participants With B-lines ≤ 15 at the Conclusion of ED AHF Management
|
7 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up through 90 days, with specific reporting of events through 30 and 90 daysTotal days alive and out of hospital through 30 and 90 days post-discharge
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up through 90 days, with specific reporting of events through 30 and 90 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From admission to pre-discharge from the hospital, on average 5 to 7 days.Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout hospitalization, on average 5-7 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Through the first 24 hours and then prior to discharge, on average 5-7 days after admissionOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up through 90 days, with specific reporting of events through 30 and 90 daysCV 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up through 90 days, with specific reporting of events through 30 and 90 days30- day and 90-day
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From admission throughout hospitalization, usually 5-7 days.Physical exam includes body weight, peripheral edema, jugular venous distention, pulmonary and cardiac auscultation
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From admission throughout hospitalization, usually 5-7 days.This is a description of which pharmacologic therapies the patient has received.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From admission throughout hospitalization, usually 5-7 days.This is a description of which pharmacologic and device therapies the patient has received.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From admission throughout hospitalization, usually 5-7 days.Calculation of intra and inter-agreement between investigators and also the Core Lab to determine the reproducibility of LUS
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up through 90 days, with specific reporting of events through 30 and 90 daysOutcome measures
Outcome data not reported
Adverse Events
LUS-guided Strategy-of-care
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Usual Care
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LUS-guided Strategy-of-care
n=66 participants at risk
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.
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
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
Usual Care
n=64 participants at risk
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.
Usual Care: Patients will receive usual AHF care
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
|---|---|---|
|
Cardiac disorders
NSTEMI
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Renal and urinary disorders
Gross hematuria
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
0.00%
0/64 • 7 days from consent
|
|
Cardiac disorders
Mitral Regurgitation, severe
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
Other adverse events
| Measure |
LUS-guided Strategy-of-care
n=66 participants at risk
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.
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
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
Usual Care
n=64 participants at risk
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.
Usual Care: Patients will receive usual AHF care
Intravenous Loop Diuretic: IV loop diuretic
Vasodilator: IV, topical, or SL Vasodilator
Non invasive Ventilation (NIV): Face, mouth, or nasal mask applied to provide positive pressure ventilation
|
|---|---|---|
|
Cardiac disorders
NSTEMI type 2
|
0.00%
0/66 • 7 days from consent
|
7.8%
5/64 • Number of events 5 • 7 days from consent
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Blood and lymphatic system disorders
MGUS, new diagnosis
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Gastrointestinal disorders
Constipation
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
0.00%
0/64 • 7 days from consent
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.1%
4/66 • Number of events 4 • 7 days from consent
|
6.2%
4/64 • Number of events 4 • 7 days from consent
|
|
Renal and urinary disorders
Hyponatremia
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
0.00%
0/64 • 7 days from consent
|
|
Vascular disorders
Hypotension
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
0.00%
0/64 • 7 days from consent
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Renal and urinary disorders
Hypotension
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/66 • 7 days from consent
|
3.1%
2/64 • Number of events 2 • 7 days from consent
|
|
Cardiac disorders
Hyponatremia
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
0.00%
0/64 • 7 days from consent
|
|
Cardiac disorders
Cough
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
0.00%
0/64 • 7 days from consent
|
|
Cardiac disorders
Supratherapeutic digoxin level
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
0.00%
0/64 • 7 days from consent
|
|
Cardiac disorders
Nonsustained ventricular tachycardia
|
1.5%
1/66 • Number of events 1 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Cardiac disorders
Mural thrombus
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Cardiac disorders
Hypotension
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/66 • 7 days from consent
|
1.6%
1/64 • Number of events 1 • 7 days from consent
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place