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Analysis of Atropine and Propranolol Induced Changes
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00251602
  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
Drug: Normal Saline
Phase I

Drug Information available for: 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 [ Time Frame: every 2 minutes during drug infusions and every 10 minutes during the remainder of the study time ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2003
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
II ACE genotype
Drug: Atropine
One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus
Drug: Propranolol
One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
2: Experimental
ID ACE genotype
Drug: Atropine
One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus
Drug: Propranolol
One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
3: Experimental
DD ACE genotype
Drug: Atropine
One-time 10 mcg/kg infusion over 30 minutes, followed by a 10 mcg/kg bolus
Drug: Propranolol
One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
4: Placebo Comparator
II ACE genotype
Drug: Propranolol
One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
Drug: Normal Saline
One-time 0.25 ml/min infusion over 30 minutes
5: Placebo Comparator
ID ACE genotype
Drug: Propranolol
One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
Drug: Normal Saline
One-time 0.25 ml/min infusion over 30 minutes
6: Placebo Comparator
DD ACE genotype
Drug: Propranolol
One-time 0.8mg/kg/hr infusion (maximum dose not to exceed 20mg) over 20 minutes, followed by either atropine or normal saline
Drug: Normal Saline
One-time 0.25 ml/min infusion over 30 minutes

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
Investigators
Principal Investigator: Shari M. Ling, MD National Institute on Aging, Clinical Research Branch
  More Information

Publications:
Responsible Party: National Institute on Aging ( Shari Ling, M.D. )
Study ID Numbers: AG0059
Study First Received: November 8, 2005
Last Updated: August 28, 2008
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
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 30, 2009