Myocardial Hemodynamic Effects of Levosimendan
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.
研究概览
简要总结
This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan.
Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congestive heart failure (CHF). Levosimendan is a new calcium sensitizer that binds to troponin C. This agent is approved in Europe for treatment of heart failure patients. In the United States, this agent is currently under phase III investigation for intravenous treatment of patients with acutely decompensated HF who have dyspnea at rest or with minimal activity. Levosimendan has been studied in these patients with acute HF and is considered experimental in the United States for this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •All patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography
- •All patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema
- •In asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure >7 mmHg, sustained left ventricular impulse, or pulmonary congestion on auscultation
- •all patients will have echocardiographic evidence of left ventricular dysfunction
排除标准
- •Under age 18
研究组 & 干预措施
1
All randomized patients receive drug.
干预措施: levosimendan (Drug)
结局指标
主要结局
Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.
时间窗: From baseline to 30-minutes after levosimendan started.
Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.
次要结局
未报告次要终点