Nitroglycerin vs. Furosemide Using Lung Ultrasound Pilot Trial

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

Although it is the investigators' belief patients are often inadequately decongested in the ED, it is common teaching within emergency medicine to focus on vasodilators and avoid or minimize diuretics, especially in those patients with elevated blood pressure. This practice is largely driven by retrospective analyses or small studies suggesting vasodilators are efficacious and IV loop diuretics may be associated with harm. The evidence base to guide early ED management is poor, and the AHA/ACC guidelines provide little to no guidance for ED treatment. This reflects the lack of high quality data, a critical unmet need that the investigators will address in this study.

Using clearance of LUS B-lines as the study endpoint, the investigators will study whether a diuretic intense vs. nitrate intense strategy achieves better decongestion. Although nearly two decades old, a small study of 100 patients suggested a nitrate intense strategy led to better outcomes in AHF patients with pulmonary edema when compared with a diuretic intense strategy. The investigators aim to perform a small pilot study, in hypertensive patients (SBP > 140mmHg) to test such a strategy to inform a larger, more definitive multicenter randomized trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Vanderbilt University
• Treatments: Diuretics; Furosemide; Nitroglycerin; Sodium Potassium Chloride Symporter Inhibitors

Criteria

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

• BNP > 500pg/mL]

Exclusion Criteria:

• 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