NCT00251602

Analysis of Atropine and Propranolol Induced Changes

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Institute on Aging (NIA) · NIH
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Atropine	One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus
DRUG	Propranolol	One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
DRUG	Normal Saline	One-time 0.25 ml/min infusion over 30 minutes

Timeline

• Start date: 2003-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2005-11-10
• Last updated: 2012-08-06

Locations

1 site across 1 country: United States