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Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

Information source: University of Colorado, Boulder
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prehypertension; Hypertension

Intervention: Nebivolol (Drug); Metoprolol (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Colorado, Boulder

Official(s) and/or principal investigator(s):
Christopher DeSouza, Ph.D., Principal Investigator, Affiliation: University of Colorado at Boulder

Overall contact:
Jared Greiner, M.S., Phone: 303-735-4955, Email: jared.greiner@colorado.edu

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.

Clinical Details

Official title: Nebivolol and Endothelial Regulation of Fibrinolysis

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome: Changes from baseline in endothelial t-PA release

Eligibility

Minimum age: 45 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Jared Greiner, M.S., Phone: 303-735-4955, Email: jared.greiner@colorado.edu

UC-Boulder Clinical and Translational Research Center, Boulder, Colorado 80309, United States; Recruiting
Phone: 303-735-3056
Christopher DeSouza, Ph.D., Principal Investigator
Additional Information

Starting date: February 2012
Last updated: December 2, 2014

Page last updated: August 23, 2015

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