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Variability in Adrenergic Response

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00838695
First Posted: February 6, 2009
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University
  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 Reaction to Medications Drug: phenylephrine and nitroglycerin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Variability in Adrenergic Response

Resource links provided by NLM:


Further study details as provided by C. Michael Stein, Vanderbilt University:

Primary Outcome Measures:
  • sensitivity to phenylephrine and nitroglycerin [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • cardiovascular responses to cold and mental stress [ Time Frame: 1 hour ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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)
Other Name: generic medications used,not applicable

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838695


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Charles M Stein, MD Vanderbilt University
  More Information

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
P01HL056693 ( U.S. NIH Grant/Contract )
1UL1RR024975 ( U.S. NIH Grant/Contract )
First Submitted: February 4, 2009
First Posted: February 6, 2009
Last Update Posted: November 1, 2016
Last Verified: October 2016

Keywords provided by C. Michael Stein, Vanderbilt University:
Hand vein sensitivity
phenylephrine
nitroglycerin

Additional relevant MeSH terms:
Phenylephrine
Oxymetazoline
Adrenergic Agents
Nitroglycerin
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vasodilator Agents