Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
Primary Purpose
Pre-hypertension, Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nebivolol
Sponsored by
About this trial
This is an interventional treatment trial for Pre-hypertension focused on measuring Genetic risk of hypertension
Eligibility Criteria
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.
Sites / Locations
- University of California, San Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nebivolol
Sugar pill
Arm Description
Outcomes
Primary Outcome Measures
Aortic Systolic Blood Pressure (SBP)
Aortic Diastolic Blood Pressure (DBP)
Aortic Mean Arterial Pressure (MAP)
Aortic Pulse Pressure
Aortic Augmentation Pressure
Aortic Augmentation Index for Heart Rate
Pulse Wave Velocity
Heart Rate, Beats Per a Minute
Secondary Outcome Measures
Urinary Nitric Oxide Excretion
Urinary Isoprostane Excretion
Urinary Hydrogen Peroxide Excretion
Plasma Interleukin Levels
Full Information
NCT ID
NCT01202175
First Posted
June 24, 2010
Last Updated
July 30, 2019
Sponsor
University of California, San Diego
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT01202175
Brief Title
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Forest Laboratories
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-hypertension, Hypertension
Keywords
Genetic risk of hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nebivolol
Arm Type
Experimental
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Other Intervention Name(s)
Bystolic
Intervention Description
Oral nebivolol 2.5-5mg once daily
Primary Outcome Measure Information:
Title
Aortic Systolic Blood Pressure (SBP)
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Aortic Diastolic Blood Pressure (DBP)
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Aortic Mean Arterial Pressure (MAP)
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Aortic Pulse Pressure
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Aortic Augmentation Pressure
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Aortic Augmentation Index for Heart Rate
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Pulse Wave Velocity
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Heart Rate, Beats Per a Minute
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Secondary Outcome Measure Information:
Title
Urinary Nitric Oxide Excretion
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Urinary Isoprostane Excretion
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
Title
Urinary Hydrogen Peroxide Excretion
Time Frame
Baseline (visit 1) and 8 Weeks (visit 2)
Title
Plasma Interleukin Levels
Time Frame
Basline (visit 1) and 8 weeks (visit 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel O'Connor, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
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