BNP as Adjuvant Therapy to Preserve Renal Function and Facilitate Diuresis in Hospitalized Patients With Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Creatinine, creatinine clearance on days 1, 2, & 3
研究概览
简要总结
Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic resistance contribute to this risk, particularly if renal dysfunction worsens during CHF treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with well-defined physiological effects which include arterial and venous vasodilation, suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of decompensated CHF as it has been demonstrated to lower filling pressures and improve symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has not been fully defined.
The objective of this clinical practice protocol is to determine whether use of BNP in addition to standard therapy, will preserve renal function and facilitate diuresis in patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60 ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure Service who meet entrance criteria will be randomized to standard clinical practice with or without a 48 hour infusion of BNP.
The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3 days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day readmission rate.
详细描述
Hypothesis:
The objective of this clinical practice protocol is to determine whether use of BNP in addition to standard therapy, will preserve renal function and facilitate diuresis in patients with CHF and renal impairment as compared to standard therapy alone. The study is targeted at patients with mild to moderate renal dysfunction with adequate blood pressure who do not require inotropic therapy and are not felt to need intravenous vasodilator therapy for acute symptom control. Patients will be randomized on admission to the heart failure service and prior to initiation of therapy. Patients who receive initial therapy in the emergency department will be eligible but the therapy given in the emergency department will be recorded.
Inclusion criteria:
- Clinical diagnosis of class III-IV CHF requiring hospitalization for treatment of CHF.
- Mild - moderate renal insufficiency (20< Creatinine Clearance < 60 ml/min as calculated by the Cockcroft-Gault formula)
- Systolic BP > 90
- Stable cardiac rhythm
- Unlikely to require cardiac catheterization
Exclusion criteria:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of class III-IV CHF requiring hospitalization for treatment of CHF.
- •Mild - moderate renal insufficiency (20< Creatinine Clearance < 60 ml/min as calculated by the Cockcroft-Gault formula)
- •Systolic BP > 90
- •Stable cardiac rhythm
- •Unlikely to require cardiac catheterization
排除标准
- •Inability to give informed consent
- •New onset atrial fibrillation with rapid ventricular response (HR >110 bpm)
- •Active ischemia
- •Known or suspected stenotic valve disease
- •Acute clinical need for intravenous vasodilator (including BNP) therapy (Severely symptomatic despite rest, oxygen, initial standard therapy)
- •Primary reason for admission other than treatment of decompensated CHF (rhythm, device, other medical problem)
结局指标
主要结局
Creatinine, creatinine clearance on days 1, 2, & 3
Weight loss on days 1, 2 & 3
Fluid balance on days 1, 2 & 3
Use of advanced therapy for diuretic resistance
Meet criteria for diuretic resistance
次要结局
- Length of stay
- 30-day re-admission for HF
- Neuro-hormonal levels (PRA, A-II, ANP, BNP, cGMP, etc)
- Hemodynamic measurements (systolic blood pressure [SBP], systolic blood pressure [DBP], mean arterial pressure [MAP])