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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00251602

Enrollment

Registered

2005-11-10

Start date

2003-03-31

Completion date

2012-08-31

Last updated

2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

heart rate variability, gene response

Brief 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.

Interventions

DRUGAtropine

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

DRUGPropranolol

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

DRUGNormal Saline

One-time 0.25 ml/min infusion over 30 minutes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Changes in heart rate and blood pressure	every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026