Analysis of Atropine and Propranolol Induced Changes - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Atropine Drug: Propranolol	Phase I

ChemIDplus related topics:

Atropine Atropine sulfate Propranolol Dexpropranolol Propranolol hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

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

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:

Changes in heart rate and blood pressure

Estimated Enrollment:	30
Study Start Date:	March 2003
Estimated Study Completion Date:	August 2006

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.

Eligibility

Ages Eligible for Study:	21 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251602

Locations


United States, Maryland
	National Institute on Aging, Harbor Hospital
	Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

National Institute on Aging (NIA)

Investigators


Principal Investigator:	Darrell R. Abernethy, MD, PhD	National Institute on Aging, Laboratory of Clinical Investigation

More Information

Publications:

Akselrod S, Gordon D, Ubel FA, Shannon DC, Berger AC, Cohen RJ. Power spectrum analysis of heart rate fluctuation: a quantitative probe of beat-to-beat cardiovascular control. Science. 1981 Jul 10;213(4504):220-2.

Craft N, Schwartz JB. Effects of age on intrinsic heart rate, heart rate variability, and AV conduction in healthy humans. Am J Physiol. 1995 Apr;268(4 Pt 2):H1441-52.

Pagani M, Lombardi F, Guzzetti S, Rimoldi O, Furlan R, Pizzinelli P, Sandrone G, Malfatto G, Dell'Orto S, Piccaluga E, et al. Power spectral analysis of heart rate and arterial pressure variabilities as a marker of sympatho-vagal interaction in man and conscious dog. Circ Res. 1986 Aug;59(2):178-93.

Study ID Numbers:	AG0059
First Received:	November 8, 2005
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00251602
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Aging (NIA):

heart rate variability

gene response

Study placed in the following topic categories:

Propranolol

Healthy

Atropine

Additional relevant MeSH terms:

Parasympatholytics

Respiratory System Agents

Vasodilator Agents

Neurotransmitter Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists

Physiological Effects of Drugs

Anti-Asthmatic Agents

Cardiovascular Agents

Antihypertensive Agents

Cholinergic Agents

Pharmacologic Actions

Muscarinic Antagonists

Adjuvants, Anesthesia

Mydriatics

Autonomic Agents

Therapeutic Uses

Adrenergic beta-Antagonists

Adrenergic Antagonists

ClinicalTrials.gov processed this record on May 11, 2008

Sponsored by:	National Institute on Aging (NIA)
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00251602