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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00251602 |
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 |
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Healthy |
Drug: Atropine Drug: Propranolol Drug: Normal Saline |
Phase I |
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 |
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 |
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1: Experimental
II ACE genotype
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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
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2: Experimental
ID ACE genotype
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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
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3: Experimental
DD ACE genotype
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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
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4: Placebo Comparator
II ACE genotype
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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
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5: Placebo Comparator
ID ACE genotype
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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
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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
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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.
Ages Eligible for Study: | 21 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
National Institute on Aging, Harbor Hospital | |
Baltimore, Maryland, United States, 21225 |
Principal Investigator: | Shari M. Ling, MD | National Institute on Aging, Clinical Research Branch |
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 History of Changes |
Health Authority: | United States: Federal Government |
heart rate variability gene response |
Vasodilator Agents Neurotransmitter Agents Adrenergic Agents Cholinergic Antagonists Adjuvants, Immunologic Anesthetics Anti-Asthmatic Agents Healthy Cardiovascular Agents Antihypertensive Agents |
Cholinergic Agents Muscarinic Antagonists Mydriatics Propranolol Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents Peripheral Nervous System Agents Bronchodilator Agents Atropine |
Respiratory System Agents Parasympatholytics Vasodilator Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Cholinergic Agents Propranolol Therapeutic Uses Adrenergic beta-Antagonists Anti-Arrhythmia Agents |
Anti-Asthmatic Agents Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Adjuvants, Anesthesia Muscarinic Antagonists Mydriatics Autonomic Agents Adrenergic Antagonists Peripheral Nervous System Agents Bronchodilator Agents Central Nervous System Agents Atropine |