Analysis of Atropine and Propranolol Induced Changes
Information source: National Institute on Aging (NIA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Atropine (Drug); Propranolol (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: National Institute on Aging (NIA) Official(s) and/or principal investigator(s):
Darrell R. Abernethy, MD, PhD, Principal Investigator, Affiliation: National Institute on Aging, Laboratory of Clinical Investigation
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.
Clinical Details
Official title: Wavelet Transform and Pharmacodynamic Analysis of Atropine and Propranolol Induced Changes in Human Heart Rate Variability
Study design: Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Changes in heart rate and blood pressure
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
Minimum age: 21 Years.
Maximum age: 40 Years.
Gender(s): Both.
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
Locations and Contacts
National Institute on Aging, Harbor Hospital, Baltimore, Maryland 21225, United States
Additional Information
Related 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.
Starting date: March 2003
Ending date: August 2006
Last updated: August 22, 2007
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