Overview

Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

Status:
Completed
Trial end date:
2017-10-01
Target enrollment:
0
Participant gender:
All
Summary
The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. The investigators further hypothesize that the improvement in the capacity of the vascular endothelium to release t-PA with nebivolol is mediated, in part, by the compound's antioxidant properties.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Colorado, Boulder
Collaborator:
Forest Laboratories
Treatments:
Ascorbic Acid
Bradykinin
Kininogens
Metoprolol
Nebivolol
Criteria
Inclusion Criteria:

- Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.

- Subjects will be prehypertensive/hypertensive defined as resting systolic blood
pressure >125 mmHg and <160 mmHg and/or diastolic >80 mmHg and <100 mmHg.

- All of the women in the study will be postmenopausal and not receiving hormone
replacement therapy (HRT) currently or in the preceding 3-year period.

- Candidates will be sedentary as determined from the Stanford Physical Activity
Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular
physical activity for at least 1 year prior to the study.

Exclusion Criteria:

- Candidates who smoke (currently or in the past 7 years), report more than low-risk
alcohol consumption as defined as no more than 14 standard drinks/wk and no more than
4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for
women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces
of 80-proof distilled spirits).

- Potential candidates who are taking cardiovascular-acting (i.e. statins, blood
pressure medication and aspirin) medications will not be eligible.

- Fasting plasma glucose >126 mg/dL.

- Potential candidates with a resting heart rate of < 50 beats/minute will be excluded.

- Use of hormone replacement therapy.

- In hypertensive subjects, a seated systolic blood pressure >160 mmHg or a seated
diastolic blood pressure >100 mmHg will be excluded.