Inhibition of Sterile Inflammation by Digoxin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
研究概览
简要总结
To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.
详细描述
To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin.
To investigation how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Digoxin 3 mcg/Kg/day
Patients receiving oral digoxin 3 mcg/Kg/day
干预措施: Digoxin (Drug)
Digoxin 0.15 mcg
Patients receiving oral digoxin 0.15 mcg/Kg/day
干预措施: Digoxin (Drug)
Placebo
oral placebo
干预措施: Placebo (Other)
结局指标
主要结局
Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production
时间窗: 3 weeks after starting digoxin
Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached.
次要结局
- Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro(6 weeks)