Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

University of Colorado Boulder (CU)

Status and phase: Completed; Phase 4

Conditions: Hypertension; Prehypertension

Treatments: Drug: Nebivolol; Other: Saline; Other: Vitamin C; Drug: Placebo; Other: Bradykinin; Drug: Metoprolol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01595516

BYS-MD-72

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 6 patient groups, including a placebo group

Nebivolol

Active Comparator group

Treatment:

Drug: Nebivolol

Metoprolol

Active Comparator group

Treatment:

Drug: Metoprolol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Bradykinin

Other group

Treatment:

Drug: Metoprolol

Other: Bradykinin

Drug: Placebo

Drug: Nebivolol

Saline

Other group

Treatment:

Drug: Metoprolol

Other: Vitamin C

Other: Bradykinin

Drug: Placebo

Other: Saline

Drug: Nebivolol

Vitamin C

Other group

Treatment:

Drug: Metoprolol

Other: Vitamin C

Other: Bradykinin

Other: Saline

Drug: Nebivolol