Analysis of Atropine and Propranolol Induced Changes
Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Atropine (Drug); Propranolol (Drug); Normal Saline (Drug)
Phase: Phase 1
Sponsored by: National Institute on Aging (NIA)
Official(s) and/or principal investigator(s):
Shari M. Ling, MD, Principal Investigator, Affiliation: National Institute on Aging, Clinical Research Branch
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.
Official title: Wavelet Transform and Pharmacodynamic Analysis of Atropine and Propranolol Induced Changes in Human Heart Rate Variability
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Changes in heart rate and blood pressure
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.
Minimum age: 21 Years.
Maximum age: 40 Years.
- Healthy male and female volunteers
- Ages 21-40
- Body Mass Index >18. 0 and <27. 0
- 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
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
Last updated: August 3, 2012