Diesel Exhaust and Vascular Function (CVDTRAP4)

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University of Washington

Status

Unknown

Conditions

Cardiovascular Effects

Treatments

Other: Diesel Exhaust
Other: Filtered Air
Drug: placebo
Drug: Terazosin

Study type

Interventional

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT01508637
P50ES015915 (U.S. NIH Grant/Contract)
39833-D

Details and patient eligibility

About

Double-blind, sham- and placebo-controlled randomized study of effects of freshly-generated diluted diesel exhaust inhalation on vascular function. To examine role of adrenergic system a trial of alpha-blocker terazosin is also used. Each participant completes four study sessions, separated by at least three weeks: 1) Diesel exhaust inhalation (DE, controlled at 300 micrograms/cubic meter for two hours) and terazosin (2 mg prior to inhalation exposure); 2) DE plus placebo (matched for terazosin); 3) filtered air plus terazosin; and 4) filter air plus placebo. The investigators assess outcomes of blood pressure, forearm brachial artery ultrasound, and plasma measures of endothelial activation. The investigators hypothesize that DE exposure will be associated with increased blood pressure, decreased brachial artery diameter, and increased circulating endothelins, and that these effects will be attenuated by terazosin administration.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • healthy without chronic illness
  • Body Mass Index 18.5 - 26.0
  • tolerates 2 mg terazosin dose without unacceptable symptoms
  • able to return for four exposure sessions

Exclusion criteria

  • any chronic disease
  • tobacco user
  • asthma
  • elevated cholesterol
  • obesity
  • hypertension
  • diabetes
  • any chronic cardiovascular or pulmonary disease
  • pregnancy or unwillingness to use effective contraception, if female

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

24 participants in 4 patient groups

Diesel Exhaust + Terazosin
Experimental group
Treatment:
Drug: Terazosin
Other: Diesel Exhaust
Diesel Exhaust + placebo
Experimental group
Treatment:
Drug: placebo
Other: Diesel Exhaust
Filtered Air + terazosin
Sham Comparator group
Treatment:
Drug: Terazosin
Other: Filtered Air
Filtered air + placebo
Sham Comparator group
Treatment:
Drug: placebo
Other: Filtered Air

Trial contacts and locations

0

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Central trial contact

Karen Jansen, M.S.

Data sourced from clinicaltrials.gov

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