Comparison of High-dose Furosemide Versus the Combination of Low-dose Furosemide and Low-dose Dopamine in Patients With Acute Decompensated Heart Failure
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
研究概览
简要总结
The aim of this study is to compare the effects of high-dose furosemide versus low-dose furosemide combined with low-dose dopamine on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
详细描述
Worsening renal function (WRF) and hypokalemia related to diuretic use for acute decompensated heart failure (ADHF) are common and portend poor prognosis. Low dose dopamine infusion improves renal perfusion. Whether dopamine infusion improves diuresis and/or reduces renal complication in ADHF is not known. The aim of this study is to compare the effects of high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours) vs. low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, renal function, electrolyte balance, and 60-day post-discharge outcomes in patients hospitalized with ADHF.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea
- •signs of congestion (third heart sound or pulmonary rales on physical examination)
- •pulmonary congestion on chest x-ray
- •serum B-type natriuretic peptide levels > 400 pg/ml or NT-proBNP > 1500 pg/ml
- •echocardiographic documentation of systolic or diastolic dysfunction
- •all candidate patients must be:
- •Age >18 years old
- •on medical therapy with an ACE-inhibitor and/or a β-blocker
- •experiencing an acute decompensation of known chronic HF
- •Having baseline oxygen saturation <90% on admission arterial blood gas
排除标准
- •the investigators will exclude patients with:
- •acute de novo HF
- •severe renal failure (serum creatinine > 200 μmol/L or GFR < 30 ml/min/1.73m2)
- •admission systolic blood pressure < 90 mm Hg
- •severe valvular disease
- •known adverse reactions to furosemide or dopamine
- •HF secondary to congenital heart disease
- •a scheduled procedure with a need for IV contrast dye
- •a scheduled cardiac surgery within 6 months
研究组 & 干预措施
High-dose furosemide
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
干预措施: Furosemide (Drug)
low-dose dopamine + low-dose furosemide
Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours
干预措施: low-dose dopamine + low-dose furosemide (Drug)
结局指标
主要结局
1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).
时间窗: 1-year
次要结局
- 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure).(60 days post discharge)