Clinical trial NCT01202175: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pre-hypertension
Hypertension
Keywords: Genetic risk of hypertension
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2010-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Aortic Systolic Blood Pressure (SBP)
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Aortic Diastolic Blood Pressure (DBP)
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Aortic Mean Arterial Pressure (MAP)
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Aortic Pulse Pressure
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Aortic Augmentation Pressure
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Aortic Augmentation Index for Heart Rate
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Pulse Wave Velocity
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Heart Rate, Beats Per a Minute
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
Secondary outcomes:
measure: Urinary Nitric Oxide Excretion
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Urinary Isoprostane Excretion
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
measure: Urinary Hydrogen Peroxide Excretion
timeFrame: Baseline (visit 1) and 8 Weeks (visit 2)
measure: Plasma Interleukin Levels
timeFrame: Basline (visit 1) and 8 weeks (visit 2)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Daniel O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References: