Analysis of Atropine and Propranolol Induced Changes - Tabular View

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Analysis of Atropine and Propranolol Induced Changes

This study is ongoing, but not recruiting participants.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Analysis of Atropine and Propranolol Induced Changes

Official Title ^†

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

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Primary Outcome Measure ^†

Changes in heart rate and blood pressure

Secondary Outcome Measure ^†

Condition ^†

Healthy

Intervention ^†

Drug: Atropine
Drug: Propranolol

MEDLINE PMIDs

6166045, 7733345, 2874900

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

March 2003

Completion Date

August 2006

Eligibility Criteria ^†

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

Gender

Both

Ages

21 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00251602

Organization ID

AG0059

Secondary IDs ^††

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Darrell R. Abernethy, MD, PhD

National Institute on Aging, Laboratory of Clinical Investigation

Information Provided By

National Institute on Aging (NIA)

Verification Date

August 2007

First Received Date ^†

November 8, 2005

Last Updated Date

August 22, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.