Nitroglycerin vs. Furosemide Using Lung Ultrasound Pilot Trial (N-FURIOUS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- The Total Number of B-lines at the Conclusion of ED AHF Management
研究概览
简要总结
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.
详细描述
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 trial is designed to provide the necessary and sufficient information for a larger, definitive trial.
PUBLIC HEALTH IMPACT:
Over one million hospitalizations for AHF occur every year in the US. Within 30 days after hospitalization, over 25% of AHF patients will be dead or re-hospitalized. By one year after hospitalization, up to 67% of patients will be re-hospitalized and 36% will be dead. Worldwide, the costs of AHF exceed 100 billion annually. For patients aged 65 years and older, AHF is the most common and most expensive reason for hospitalization. Despite major reductions in morbidity and mortality for chronic HF, considerably less progress has been seen in AHF.
The emergency department (ED) initiates diagnosis and management for the vast majority of AHF patients. Nearly 80% of all admissions originate from the ED. Delays in diagnosis, misdiagnosis, and delayed or improper treatment are costly, associated with greater morbidity and mortality. Despite this crucial starting role, ED AHF pharmacological management today is largely the same as 40 years ago. In fact, guidelines state: "the treatment of AHF remains largely opinion-based with little good evidence to guide therapy." Consensus statements from the American Heart Association as well as a working group from the NHLBI on ED AHF management further corroborate this lack of evidence: "the evidence base on which this foundation of acute care is built is astonishly thin." There remains a critical unmet need for evidence based ED AHF management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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]
排除标准
- •Chronic renal dysfunction, including ESRD or eGFR < 20 ml//min/1.73m
- •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
- •Allergy or hypersensitivity to nitroglycerin, furosemide or sulfa
- •Concern for cardiac tamponade or restrictive cardiomyopathy
- •Elevated intracranial pressure
- •Recent use of PDE5 inhibitors
研究组 & 干预措施
Diuretic Intense Strategy
Patients randomized to the Diuretic intense strategy will be treated according to protocol with IV loop diuretics in combination with nitrates. This protocol only involves therapies used in everyday AHF clinical practice.
干预措施: Loop Diuretics (Drug)
Nitrate Intense Strategy
Patients randomized to the Nitrate intense strategy will be treated according to protocol with nitrates in combination with IV loop diuretics. This protocol only involves therapies used in everyday AHF clinical practice.
干预措施: Nitrates (Drug)
结局指标
主要结局
The Total Number of B-lines at the Conclusion of ED AHF Management
时间窗: During the ED phase of management, no more than 6 hours
The total number of B-lines at the conclusion of ED AHF management or maximum of 6 hours after enrollment, whichever comes first.
次要结局
- Dyspnea Assessment(During the ED phase of management, no more than 6 hours)
- B-lines <= 15 at the Conclusion of ED AHF Management(During the ED phase of management, no more than 6 hours)
研究者
PETER S PANG
Associate Professor
Indiana University