Wavelet Transform and Pharmacodynamic Analysis of Atropine and Propranolol Induced Changes in Human Heart Rate Variability
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in heart rate and blood pressure
研究概览
简要总结
The purpose of this study is to learn the effects of genetic make up on response to the drugs atropine and propranolol, to examine how changes in heart rate and blood pressure can be measured, and to test a new statistical analysis method.
详细描述
Healthy volunteers will be recruited and screened for eligibility. Participants will be placed into three possible groups based on genetic information obtained during screening. Rolling admissions will continue until at least 10 participants have been recruited for each genetic group. Participants will be randomly assigned to receive either the control (propranolol and saline) or combined drug (propranolol and atropine) treatment in a non-blinded fashion. The participant will return over one week later to receive the alternate treatment. Continuous heart rate/blood pressure data will be recorded until the end of the study period. Respiratory rate will be maintained at a fixed rate. Participants will undergo an orthostasis task, receive the drug or control infusions, and blood samples will then be obtained to determine drug concentrations at specific time intervals. Several relatively new mathematical techniques will be applied to the data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers
- •Ages 21-40
- •Body Mass Index >18.0 and <27.0
排除标准
- •History of any chronic illnesses including cardiac diseases and bleeding problems
- •Drug use of any kind
- •Participation in any clinical trial within the last month
- •Tobacco use and/or alcohol abuse
- •Use of dietary supplements and unwillingness to refrain
研究组 & 干预措施
1
II ACE genotype
干预措施: Atropine (Drug)
1
II ACE genotype
干预措施: Propranolol (Drug)
2
ID ACE genotype
干预措施: Atropine (Drug)
2
ID ACE genotype
干预措施: Propranolol (Drug)
3
DD ACE genotype
干预措施: Atropine (Drug)
3
DD ACE genotype
干预措施: Propranolol (Drug)
4
II ACE genotype
干预措施: Propranolol (Drug)
4
II ACE genotype
干预措施: Normal Saline (Drug)
5
ID ACE genotype
干预措施: Propranolol (Drug)
5
ID ACE genotype
干预措施: Normal Saline (Drug)
6
DD ACE genotype
干预措施: Propranolol (Drug)
6
DD ACE genotype
干预措施: Normal Saline (Drug)
结局指标
主要结局
Changes in heart rate and blood pressure
时间窗: every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time
次要结局
未报告次要终点
