Status:
TERMINATED
Nitroglycerin vs. Furosemide Using Lung Ultrasound Pilot Trial
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Vanderbilt University
Conditions:
Heart Failure
Heart Failure Acute
Eligibility:
All Genders
21+ years
Phase:
PHASE2
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-h...
Detailed Description
The primary goal of the N-FURIOUS pilot trial is to determine whether a nitrate intense strategy safely reduces congestion, defined by LUS B-lines, better than a diuretic intense strategy. This pilot...
Eligibility Criteria
Inclusion
- 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:
- \[Chest radiograph consistent with AHF
- Jugular venous distension
- Pulmonary rales on auscultation
- Lower extremity edema
- BNP \> 500pg/mL\]
Exclusion
- Chronic renal dysfunction, including ESRD or eGFR \< 20 ml//min/1.73m2.
- Shock of any kind. Any requirement for vasopressors or inotropes.
- SBP \< 120
- Need for immediate intubation
- Acute Coronary Syndrome OR new ST-segment elevation/depression on EKG. (troponin release outside of ACS is allowed)
- Fever \>101.5ºF
- 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
- Severe valvular disease
- Anuria
- Allergy or hypersensitivity to nitroglycerin, furosemide or sulfa
- Concern for cardiac tamponade or restrictive cardiomyopathy
- Elevated intracranial pressure
- Recent use of PDE5 inhibitors
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03259165
Start Date
December 14 2017
End Date
December 31 2021
Last Update
August 20 2024
Active Locations (3)
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1
Eskenazi Health
Indianapolis, Indiana, United States, 46202
2
IU Health Methodist Hospital
Indianapolis, Indiana, United States, 46202
3
Vanderbilt University
Nashville, Tennessee, United States, 37235