Hypoxia-Inducible Transcription Factor 1 (HIF-1)in Vascular Aging
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Define change from baseline cerebral blood flow after receiving DFO infusion.
研究概览
简要总结
The purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (HIF-1 protein) and to see if there is a corresponding increase in blood flow to the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults between the ages of 18-80 years.
排除标准
- •subjects taking vasoactive medications,
- •hypertension,
- •pregnant women, smokers,
- •diabetes mellitus,
- •intracranial or carotid stenosis,
- •hepatic disease,
- •renal disease,
- •bone marrow suppression,
- •cardiac disease,
- •heart failure,
- •iron deficiency,
- •history of cancer,
- •history of head trauma,
- •subarachnoid hemorrhage,
- •central nervous system vasculitis,
- •multiple sclerosis,
- •migraines,
- •seizures,
- •sickle cell disease or trait,
- •cardiac arrhythmia,
- •unable to give informed consent, or
- •poor transcranial Doppler insonation windows.
研究组 & 干预措施
Healthy young
Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.
干预措施: desferrioxamine (Drug)
healthy old
Each subject comes for 2 visits. There is a randomized, double-blind, crossover design so each subject will receive active drug during one visit and placebo during the other.
干预措施: desferrioxamine (Drug)
结局指标
主要结局
Define change from baseline cerebral blood flow after receiving DFO infusion.
时间窗: baseline, 3hr, 6hr, 9hr
Cerebral blood flow is measured with transcranial Doppler ultrasound at baseline and then study drug is initiated. Blood flow is measured again after 3 hours of infusion, 6 hours of infusion, then once more 3 hours after the infusion is complete.
Determine if DFO changes blood HIF-1 levels from baseline and whether this correlates with changes in cerebrovascular hemodynamics.
时间窗: baseline, 3hr, 6hr, 9hr
Blood samples are taken at each time point and will be correlated with ultrasound blood flow measures taken at baseline, 3hrs of infusion, 6hrs of infusion, and 3 hours after infusion is complete.
次要结局
未报告次要终点
研究者
Farzaneh Sorond
Principle Investigator
Brigham and Women's Hospital