Nitroglycerin vs. Furosemide Using Lung Ultrasound 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.

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.

Conditions

• Heart Failure
• Heart Failure Acute
• Acute Cardiac Failure
• Acute Cardiac Pulmonary Edema

Interventions

DRUG

Nitrates

For patients randomized to the Nitrate intense arm, the treatment 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) (All patients receive at minimum 20 mg IV furosemide or equivalent) 2. SL nitroglycerin (400 ucg) will be given every 5 minutes, a total of three times. (May be repeated) (Held if SBP decreases to \< 120 mmHg) 3. Reassessment every 2 hours. If LUS B-lines \>15, repeat step 2. If \< 15, stop algorithm.

DRUG

Loop Diuretics

For patients randomized to the Diuretic intense arm, the treatment 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. Patients receive 1 inch topical nitropaste 2. IV Loop diuretic dose = patients total oral dose (max dose of 200 mg IV) 3. Reassessment every 2 hours. If LUS B-lines \>15, repeat step 2. If \< 15, stop algorithm.

Sponsors & Collaborators

• Vanderbilt University

  collaborator OTHER

• Indiana University

  lead OTHER

Principal Investigators

• Peter S Pang, MD · Indiana University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-14

Primary Completion

2021-12-31

Completion

2021-12-31

FDA Drug

Yes

Countries

• United States

Study Locations