Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension

Study Overview
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Brief Summary
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The investigators aim to evaluate subjects at high risk of future development of hypertension, those with a family history of hypertension and/or that already have high normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to investigate whether these subjects have the same markers (such as microscopic protein in the urine or C-reactive protein in the blood) in the blood and urine that people with high blood pressure have, and whether they are improved before and after taking the beta-blocker nebivolol.

Official Title
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Effects of the Novel Beta-adrenergic Antagonist Nebivolol (Bystolic) on Prehypertensive Subjects at Genetic Risk of Hypertension: Implications for Inflammation, Endothelial Dysfunction, and Oxidative Stress.

Conditions
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Pre-hypertension, Hypertension

Intervention / Treatment
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* Drug: Nebivolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Prehypertensive male and female subjects with SBP =120-139 or DBP =80-89 with at least one known family member (must be diagnosed prior to the age of 60) with essential hypertension (confirmation may be sought). All ethnicities Non-smokers and non-drug abusers, no current smoking or illicit drug use in the prior 3 months. Aged 18-40 years No known serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus Subjects will need to remain in the San Diego area for the duration of the study (10 weeks) and be accessible by telephone or email. Female subjects must be willing to use a birth control method, such as abstinence, birth control pills, diaphragm, condom, or intrauterine device to prevent pregnancy during the study. Exclusion Criteria: Subjects with SBP >140 or SBP<120 or DBP >90 and DBP<80 We will exclude subjects whose family members have known secondary etiologies for hypertension such as hyperaldosteronism or Cushing's Disease. Subjects cannot have a chronic medical condition that is actively treated by a physician, such as liver impairment, diabetes, or kidney disease History of bronchial asthma or chronic obstructive pulmonary disease Subjects cannot be on any anti-hypertensive medications for any reason. Subjects may not have previous intolerance, hypersensitivity, or allergy to any beta blocker therapy or may have contraindications to beta blocker therapy such as asthma, bradycardia, etc. Subjects may not be taking medications which may affect the metabolism of nebivolol, such as those that inhibit CYP2D6 (such as fluoxetine or cimetidine) Nursing women, pregnant women, or those that plan to become pregnant in the study period will also be excluded. (Pregnancy tests will be performed on all female subjects at the start of the study) Subjects with pulse rate consistently <60 beats per minute or evidence of arrythmias including atrioventricular block. Those that have smoked or used illicit drugs within the past 3 months Female subjects that are not willing to use a birth control method, such as abstinence, birth control pills, diaphragm, condom, or intrauterine device to prevent pregnancy during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebivolol<br> | Drug: Nebivolol<br>* Oral nebivolol 2.5-5mg once daily<br>* Other names: Bystolic;|
| Placebo Comparator: Sugar pill<br> | Drug: Nebivolol<br>* Oral nebivolol 2.5-5mg once daily<br>* Other names: Bystolic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic Systolic Blood Pressure (SBP) |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Aortic Diastolic Blood Pressure (DBP) |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Aortic Mean Arterial Pressure (MAP) |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Aortic Pulse Pressure |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Aortic Augmentation Pressure |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Aortic Augmentation Index for Heart Rate |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Pulse Wave Velocity |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Heart Rate, Beats Per a Minute |  | Basline (visit 1) and 8 weeks (visit 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Nitric Oxide Excretion |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Urinary Isoprostane Excretion |  | Basline (visit 1) and 8 weeks (visit 2) | 
| Urinary Hydrogen Peroxide Excretion |  | Baseline (visit 1) and 8 Weeks (visit 2) | 
| Plasma Interleukin Levels |  | Basline (visit 1) and 8 weeks (visit 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genetic risk of hypertension