Aspirin as a Novel Anti-Inflammatory Modality in the Fontan Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Total Cholesterol
研究概览
简要总结
Patients who have undergone the Fontan procedure (a congenital heart surgery) may develop complications many years after their operation. Studies have shown that some of these patients develop an ongoing inflammatory state, which may be the cause of these late complications. Aspirin is a common over the counter anti-inflammatory medication used for many other chronic diseases. This study may help determine if aspirin therapy can limit the inflammation seen in Fontan patients and prevent these late complications.
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
- •Adults who have Fontan repair of single ventricle
排除标准
- •Persons with the following history, conditions, or behavior will be excluded
- •Active protein losing enteropathy within the past three years
- •Congestive heart failure
- •Active arrhythmias
- •Taking Coumadin (Warfarin)
- •Bleeding disorder
- •Known esophageal varicies
- •Consuming more than 10 alcoholic drinks per week.
- •Planning to become pregnant
研究组 & 干预措施
Intervention: aspirin
650 mg. Twice a day for 8 weeks
干预措施: Aspirin (Drug)
结局指标
主要结局
Change in Total Cholesterol
时间窗: 8 weeks
Change will be measured from baseline to retest after 8 weeks of treatment
Change in HDL (High-Density Lipoprotein)-Cholesterol
时间窗: 8 weeks
Change will be measured from baseline to retest after 8 weeks of treatment
次要结局
- High Sensitivity CRP(C-Reactive Protein)(8 weeks)
- Quality of Life(8 weeks)
研究者
Adam Lubert
Clinical Instructor, Pediatric Cardiology
University of Michigan