Proteolytic Enzyme Induction Within the Human Myocardial Interstitium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Pulmonary Vascular Resistance
研究概览
简要总结
A robust release of endothelin-1-1 (ET) with subsequent ETA subtype receptor (ET-AR) activation occurs in patients following cardiac surgery requiring cardiopulmonary bypass (CPB). Increased ET-AR activation has been identified in patients with poor left ventricular (LV) function (reduced ejection fraction; EF). Accordingly, this study tested the hypothesis that a selective ET-AR antagonist (ET-ARA) administered peri-operatively would favorably affect post-CPB hemodynamic profiles in patients with a pre-existing poor LVEF.
详细描述
Patients with a reduced LVEF were prospectively randomized, in a blinded fashion, at the time of elective coronary revascularization and/or valve replacement requiring CPB, to infusion of the highly-selective and potent ET-ARA, sitaxsentan at 1 or 2 mg/kg (IV bolus) or vehicle (saline). Infusion of the ET-ARA/vehicle was performed immediately prior to separation from CPB and again at 12 hrs post-CPB. ET and hemodynamic measurements were performed at baseline, at separation from CPB (Time 0) and at 0.5, 6, 12, 24 hrs post-CPB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>60 years of age
- •Body mass index <40 kg/m2
- •Left ventricular ejection fraction less than or equal to 50% documented by a pre-operative echocardiogram
- •Patients undergoing coronary artery bypass (CABG), aortic and/or mitral valve replacement or combined CABG and valve procedures requiring CPB.
- •If diabetic, be under proper control, (fasting glucose <350 mg/dL or recent hemoglobin A1c [HgbA1c] <9%).
- •If hypertensive, be on a stable medical regimen with no significant changes over the past 30 days.
- •Female of child bearing potential with a negative pregnancy test, or post-menopausal for at least 2 years
- •The patient is an appropriate study candidate as determined by the Investigator on the basis of medical history and physical examination
排除标准
- •Emergent revascularization
- •Previous stroke or thrombo-embolic event in the 3 months prior to study entry
- •A previous myocardial infarction within the last 7 days
- •Documented coagulopathy
- •Hepatic dysfunction as defined by aspartate transaminase (AST) or alanine transaminase (ALT) > 1.5 times the upper limit of normal
- •Patient is pregnant or breastfeeding
研究组 & 干预措施
ET-ARA 2mg/kg
ET-ARA 2 mg/kg
干预措施: 2mg/kg sitaxsentan sodium (Drug)
Vehicle
Vehicle Group
干预措施: Vehicle (Other)
ET-ARA 1mg/kg
ET-ARA 1 mg/kg
干预措施: 1mg/kg sitaxsentan sodium (Drug)
结局指标
主要结局
Pulmonary Vascular Resistance
时间窗: Baseline, 0, 6, 12 and 24 hours post-cardiopulmonary bypass (CPB)
Pulmonary Vascular Resistance (d.s.cm-5)
次要结局
- Plasma Endothelin-1(Baseline, 0, 6, 12 and 24 hours post-CPB)