Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prehypertension Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Nebivolol

Group Type ACTIVE_COMPARATOR

Nebivolol

Intervention Type DRUG

5 mg tablet to be taken by mouth once per day for 12 weeks

Metoprolol

Group Type ACTIVE_COMPARATOR

Metoprolol

Intervention Type DRUG

100 mg tablet to be taken by mouth once per day for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Gelatin capsule to be taken by mouth once per day for 12 weeks

Bradykinin

Group Type OTHER

Nebivolol

Intervention Type DRUG

5 mg tablet to be taken by mouth once per day for 12 weeks

Metoprolol

Intervention Type DRUG

100 mg tablet to be taken by mouth once per day for 12 weeks

Placebo

Intervention Type DRUG

Gelatin capsule to be taken by mouth once per day for 12 weeks

Bradykinin

Intervention Type OTHER

Bradykinin is infused into the brachial artery at doses of 12.5, 25.0 and 50.0 ng/100 mL of forearm tissue /min. BDK stimulates the endothelial cells to release tissue type plasminogen activator (t-PA). Blood flow in mL/100 mL tissue/min is also measured to BDK.

Saline

Group Type OTHER

Nebivolol

Intervention Type DRUG

5 mg tablet to be taken by mouth once per day for 12 weeks

Metoprolol

Intervention Type DRUG

100 mg tablet to be taken by mouth once per day for 12 weeks

Placebo

Intervention Type DRUG

Gelatin capsule to be taken by mouth once per day for 12 weeks

Bradykinin

Intervention Type OTHER

Bradykinin is infused into the brachial artery at doses of 12.5, 25.0 and 50.0 ng/100 mL of forearm tissue /min. BDK stimulates the endothelial cells to release tissue type plasminogen activator (t-PA). Blood flow in mL/100 mL tissue/min is also measured to BDK.

Saline

Intervention Type OTHER

Baseline or resting forearm blood flow is measured in response to saline for 5 minutes before each drug infusion. t-PA release in response to the saline is also measured.

Vitamin C

Intervention Type OTHER

The acute effects of into-arterial vitamin C on the ability of the endothelium to release t-PA was determined before and after the nebivolol and metoprolol intervention. After allowing sufficient time (\~20 minutes) for FBF and plasma t-PA concentrations to return to baseline following the initial infusion of BDK, vitamin C (24 mg/min) was infused at a constant rate while the BDK dose-response curves were repeated. t-PA and FBF were measured.

Vitamin C

Group Type OTHER

Nebivolol

Intervention Type DRUG

5 mg tablet to be taken by mouth once per day for 12 weeks

Metoprolol

Intervention Type DRUG

100 mg tablet to be taken by mouth once per day for 12 weeks

Bradykinin

Intervention Type OTHER

Bradykinin is infused into the brachial artery at doses of 12.5, 25.0 and 50.0 ng/100 mL of forearm tissue /min. BDK stimulates the endothelial cells to release tissue type plasminogen activator (t-PA). Blood flow in mL/100 mL tissue/min is also measured to BDK.

Saline

Intervention Type OTHER

Baseline or resting forearm blood flow is measured in response to saline for 5 minutes before each drug infusion. t-PA release in response to the saline is also measured.

Vitamin C

Intervention Type OTHER

The acute effects of into-arterial vitamin C on the ability of the endothelium to release t-PA was determined before and after the nebivolol and metoprolol intervention. After allowing sufficient time (\~20 minutes) for FBF and plasma t-PA concentrations to return to baseline following the initial infusion of BDK, vitamin C (24 mg/min) was infused at a constant rate while the BDK dose-response curves were repeated. t-PA and FBF were measured.

Interventions

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Nebivolol

5 mg tablet to be taken by mouth once per day for 12 weeks

Intervention Type DRUG

Metoprolol

100 mg tablet to be taken by mouth once per day for 12 weeks

Intervention Type DRUG

Placebo

Gelatin capsule to be taken by mouth once per day for 12 weeks

Intervention Type DRUG

Bradykinin

Bradykinin is infused into the brachial artery at doses of 12.5, 25.0 and 50.0 ng/100 mL of forearm tissue /min. BDK stimulates the endothelial cells to release tissue type plasminogen activator (t-PA). Blood flow in mL/100 mL tissue/min is also measured to BDK.

Intervention Type OTHER

Saline

Baseline or resting forearm blood flow is measured in response to saline for 5 minutes before each drug infusion. t-PA release in response to the saline is also measured.

Intervention Type OTHER

Vitamin C

The acute effects of into-arterial vitamin C on the ability of the endothelium to release t-PA was determined before and after the nebivolol and metoprolol intervention. After allowing sufficient time (\~20 minutes) for FBF and plasma t-PA concentrations to return to baseline following the initial infusion of BDK, vitamin C (24 mg/min) was infused at a constant rate while the BDK dose-response curves were repeated. t-PA and FBF were measured.

Intervention Type OTHER

Other Intervention Names

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Bystolic Toprol-XL BDK

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes