Overview

This trial is active, not recruiting.

Condition vascular reaction to medications
Treatment phenylephrine and nitroglycerin
Sponsor Vanderbilt University
Start date January 2009
End date December 2016
Trial size 200 participants
Trial identifier NCT00838695, 71148, P01 HL56693, UL 1 RR024975

Summary

The goal of this project is to determine the genetic factors contributing to interindividual differences in response to physiological and pharmacological vasoconstrictors and vasodilators.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
Subjects undergo hand vein testing with phenylephrine and nitroglycerin and then mental stress and cold pressor testing
phenylephrine and nitroglycerin generic medications used,not applicable
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)

Primary Outcomes

Measure
sensitivity to phenylephrine and nitroglycerin
time frame: 1 day

Secondary Outcomes

Measure
cardiovascular responses to cold and mental stress
time frame: 1 hour

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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.

Additional Information

Official title Variability in Adrenergic Response
Principal investigator Charles M Stein, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.