Variability in Adrenergic Response

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. Michael Stein, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00838695
First received: February 4, 2009
Last updated: July 3, 2013
Last verified: July 2013
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Variability in Adrenergic Response

Resource links provided by NLM:


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 2014
Estimated Primary Completion Date: December 2014 (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

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
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: 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: July 3, 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 July 22, 2014