Variability in Adrenergic Response
This study is ongoing, but not recruiting participants.
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00838695
First received: February 4, 2009
Last updated: January 10, 2013
Last verified: January 2013
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Purpose
The goal of this project is to determine the genetic factors contributing to interindividual differences in response to physiological and pharmacological vasoconstrictors and vasodilators.
| Condition | Intervention |
|---|---|
|
Vascular Sensitivity |
Drug: phenylephrine and nitroglycerin |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Variability in Adrenergic Response |
Resource links provided by NLM:
Drug Information available for:
Nitroglycerin
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
U.S. FDA Resources
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- sensitivity to phenylephrine and nitroglycerin [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- cardiovascular responses to cold and mental stress [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vascular sensitivity
Subjects undergo hand vein testing with phenylephrine and nitroglycerin and then mental stress and cold pressor testing
|
Drug: phenylephrine and nitroglycerin
Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)
|
Detailed Description:
The dorsal hand vein model is a relatively non-invasive and robust experimental model to examine the local in vivo effect of vasoactive drugs without elucidating systemic counterregulatory reflexes. Infusion of incremental low doses of phenylephrine into a dorsal hand vein results in increasing local venoconstriction, without systemic effects. Similarly, infusion of incremental low doses of nitroglycerin into a preconstricted dorsal hand vein results in increasing local venodilation, without systemic effects. Systemic vascular responses can be measured by the cold pressor test (CPT),that leads to increase in blood pressure and heart rate , or mental stress that is also known to stimulate cardiovascular responses. Individuals vary in their local and systemic vascular responses but the genetic determinants of these are not clear.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Age between 18 and 40 years, inclusive.
- Subject must be willing to give written informed consent and be able to adhere to diet and study schedules.
- Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
- Subjects must have a normal or clinically acceptable physical examination and ECG.
- Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator.
Exclusion Criteria:
- Any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within two weeks prior to study drug administration.
- Subjects who are presently, or were formerly, narcotic addicts or alcoholics.
- Subjects who have a clinically significant allergy/intolerance to phenylephrine.
- Females with a positive serum/urine pregnancy test at screening.
- Females who are nursing.
- Subject using sildenafil or other phosphodiesterase inhibitors.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838695
Locations
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | Charles M Stein, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | C. Michael Stein, Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00838695 History of Changes |
| Other Study ID Numbers: | 71148, P01 HL56693, UL 1 RR024975 |
| Study First Received: | February 4, 2009 |
| Last Updated: | January 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Vanderbilt University:
|
Hand vein sensitivity phenylephrine nitroglycerin |
Additional relevant MeSH terms:
|
Adrenergic Agents Phenylephrine Oxymetazoline Nitroglycerin Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Vasodilator Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-1 Receptor Agonists |
Adrenergic alpha-Agonists Adrenergic Agonists Cardiotonic Agents Mydriatics Autonomic Agents Peripheral Nervous System Agents Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Protective Agents |
ClinicalTrials.gov processed this record on May 21, 2013