Analysis of Atropine and Propranolol Induced Changes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00251602
First received: November 8, 2005
Last updated: August 3, 2012
Last verified: August 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Wavelet Transform and Pharmacodynamic Analysis of Atropine and Propranolol Induced Changes in Human Heart Rate Variability

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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 ]

Enrollment: 24
Study Start Date: March 2003
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Experimental: 2
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
Experimental: 3
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
Placebo Comparator: 4
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
Other Name: NS
Placebo Comparator: 5
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
Other Name: NS
Placebo Comparator: 6
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
Other Name: NS

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier: NCT00251602     History of Changes
Other Study ID Numbers: AG0059
Study First Received: November 8, 2005
Last Updated: August 3, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
heart rate variability
gene response

Additional relevant MeSH terms:
Atropine
Propranolol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on July 23, 2014