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临床试验/NCT00251602
NCT00251602已完成1 期

Wavelet Transform and Pharmacodynamic Analysis of Atropine and Propranolol Induced Changes in Human Heart Rate Variability

National Institute on Aging (NIA)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2003年3月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

II ACE genotype

干预措施: Atropine (Drug)

1

Experimental

II ACE genotype

干预措施: Propranolol (Drug)

2

Experimental

ID ACE genotype

干预措施: Atropine (Drug)

2

Experimental

ID ACE genotype

干预措施: Propranolol (Drug)

3

Experimental

DD ACE genotype

干预措施: Atropine (Drug)

3

Experimental

DD ACE genotype

干预措施: Propranolol (Drug)

4

Placebo Comparator

II ACE genotype

干预措施: Propranolol (Drug)

4

Placebo Comparator

II ACE genotype

干预措施: Normal Saline (Drug)

5

Placebo Comparator

ID ACE genotype

干预措施: Propranolol (Drug)

5

Placebo Comparator

ID ACE genotype

干预措施: Normal Saline (Drug)

6

Placebo Comparator

DD ACE genotype

干预措施: Propranolol (Drug)

6

Placebo Comparator

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

研究者

发起方
National Institute on Aging (NIA)
申办方类型
Nih
责任方
Sponsor

研究点 (1)

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Analysis of Atropine and Propranolol Induced Changes | 临床试验