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

Phase 4

Completed

• Conditions: Pre-hypertension; Hypertension
• Interventions: Drug: Nebivolol

• Registration Number: NCT01202175
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-24
• Study Start: 2010-07
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Primary Completion: 2012-06
• Study Completion: 2013-06
• Status Verified: 2019-07
• Results First Submitted: 2019-07-09
• Results First Submitted QC: 2019-07-30
• Last Update Submitted: 2019-07-30
• Results First Posted: 2019-08-21
• Last Update Posted: 2019-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Nebivolol	-
Nebivolol	Nebivolol	-

Primary Outcome Measures

Name	Time	Method
Aortic Augmentation Pressure	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 Index for Heart Rate	Basline (visit 1) and 8 weeks (visit 2)
Aortic Systolic Blood Pressure (SBP)	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

Name	Time	Method
Plasma Interleukin Levels	Basline (visit 1) and 8 weeks (visit 2)
Urinary Nitric Oxide Excretion	Basline (visit 1) and 8 weeks (visit 2)
Urinary Hydrogen Peroxide Excretion	Baseline (visit 1) and 8 Weeks (visit 2)
Urinary Isoprostane Excretion	Basline (visit 1) and 8 weeks (visit 2)

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States