Efficacy of Intravenous Levosimendan Compared With Dobutamine on Renal Hemodynamics and Function in Chronic Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in glomerular filtration rate
研究概览
简要总结
Although inotropes have a favorable effect on central hemodynamics in patients with heart failure, their effect on renal hemodynamics is incompletely defined. The purpose of this study is to evaluate the efficacy of a 75 min intravenous infusion of levosimendan compared to a 75 min infusion of dobutamine on renal hemodynamics and function in patients with chronic heart failure and signs of cardiorenal syndrome. The investigators hypothesis is that patients treated with levosimendan will show greater increases in renal blood flow and glomerular filtration rate (GFR) than those treated with dobutamine.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Written, signed and dated informed consent
- •Male and Female subjects ≥18 years of age
- •Chronic congestive heart failure scheduled for right sided cardiac catheterization
- •Left ventricular ejection fraction ≤ 40% determined by echocardiography
- •Elevation of N Terminal-proBNP ≥ 500 ng/L
- •Cardiorenal syndrome (30ml/min ≤ estimated GFR ≤ 80 ml/min (MDRD)
排除标准
- •Acute heart failure, untreated
- •Systolic blood pressure < 80 mmHg
- •Tachycardia above 100 bpm
- •Angina Canadian Cardiovascular Society (CCS) class III or higher
- •Aortic stenosis
- •Hypertrophic cardiomyopathy
- •Restrictive cardiomyopathy
- •The presence of kidney disease diagnosed before heart failure
- •Administration of radiographic contrast < 1 week
- •Radiographic contrast allergy
- •In the Investigator's opinion, the patient has a clinically significant disease that could be adversely affected by study participation
研究组 & 干预措施
Levosimendan
Levosimendan administration is initiated with a loading dose of 12μg/kg given over 10 min followed by a continuous infusion of 0.1 μg/kg/min for 65 min.
干预措施: Levosimendan (Drug)
Dobutamine
Dobutamine is given as a continuous infusion without a bolus dose. The infusion rate is started at 5.0 μg/kg/min for 10 minutes, and thereafter increased to 7,5 μg/kg/min for 65 min.
干预措施: Dobutamine (Drug)
结局指标
主要结局
Change in glomerular filtration rate
时间窗: 75 min minus baseline
Chrome-ethylenediaminetetraacetic acid (EDTA) infusion clearance
Change in renal blood flow
时间窗: 75 min minus baseline
Para-aminohippuric acid (PAH) infusion clearance
次要结局
- Change in renal vascular resistance(75 min minus baseline)
- Change in renal oxygen consumption and oxygen extraction(75 min minus baseline)
- Change in central hemodynamics(75 min minus baseline)
- Change in filtration fraction(75 min minus baseline)