Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Prehypertension; Hypertension	Drug: Nebivolol; Drug: Metoprolol; Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	54 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Other
Official Title:	Nebivolol and Endothelial Regulation of Fibrinolysis
Study Start Date :	February 2012
Actual Primary Completion Date :	October 2017
Actual Study Completion Date :	October 2017

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: Nebivolol	Drug: Nebivolol; 5 mg tablet to be taken by mouth once per day for 12 weeks; Other Name: Bystolic
Active Comparator: Metoprolol	Drug: Metoprolol; 100 mg tablet to be taken by mouth once per day for 12 weeks; Other Name: Toprol-XL
Placebo Comparator: Placebo	Drug: Placebo; Gelatin capsule to be taken by mouth once per day for 12 weeks

Outcome Measures

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Primary Outcome Measures :

1. Changes from baseline in endothelial t-PA release [ Time Frame: t-PA release will be measured at week 3 (before the 12 week drug or placebo intervention) and at week 15 (after the 12 week drug or placebo intervention). ]
   t-PA release is measured in response the bradykinin, sodium nitroprusside, vitamin C and bradykinin+vitamin C

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Colorado
UC-Boulder Clinical and Translational Research Center
Boulder, Colorado, United States, 80309

Sponsors and Collaborators

University of Colorado, Boulder

Forest Laboratories

Investigators

Principal Investigator:	Christopher DeSouza, Ph.D.	University of Colorado at Boulder

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stauffer BL, Dow CA, Diehl KJ, Bammert TD, Greiner JJ, DeSouza CA. Nebivolol, But Not Metoprolol, Treatment Improves Endothelial Fibrinolytic Capacity in Adults With Elevated Blood Pressure. J Am Heart Assoc. 2017 Nov 9;6(11). pii: e007437. doi: 10.1161/JAHA.117.007437.

Responsible Party:	Christopher DeSouza, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier:	NCT01595516 History of Changes
Other Study ID Numbers:	BYS-MD-72
First Posted:	May 10, 2012
Last Update Posted:	October 26, 2017
Last Verified:	October 2017

Additional relevant MeSH terms:

Prehypertension; Vascular Diseases; Cardiovascular Diseases; Metoprolol; Nebivolol; Anti-Arrhythmia Agents; Antihypertensive Agents; Sympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Adrenergic beta-1 Receptor Antagonists; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Adrenergic beta-1 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists