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Completed

NCT Number: NCT00251602

Analysis of Atropine and Propranolol Induced Changes

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.

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Key information

Conditions

Healthy

Age range

21 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Institute on Aging, Harbor Hospital

Baltimore, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female volunteers
  • Ages 21-40
  • Body Mass Index >18.0 and <27.0

Exclusion criteria

  • 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

Treatment and study plan

Atropine

Drug

One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus

Propranolol

Drug

One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline

normal saline

Drug

One-time 0.25 ml/min infusion over 30 minutes

Other names: NS

Primary outcomes

  1. Changes in heart rate and blood pressure

    Time frame: every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time

Sponsors and collaborators

Lead sponsor

National Institute on Aging (NIA)

Nih

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2005
Registry last updated
Aug 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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