Phase 4 N=50 Randomized Single-blind Treatment

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

Pre-hypertension · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT01202175 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Aortic Systolic Blood Pressure (SBP) — 112.7; 107.7; 106.2; 106.6 mm Hg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Nebivolol (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Aortic Systolic Blood Pressure (SBP)	112.7; 107.7; 106.2; 106.6	—
PRIMARY Aortic Diastolic Blood Pressure (DBP)	79.1; 75.9; 71.3; 74	—
PRIMARY Aortic Mean Arterial Pressure (MAP)	94.2; 90.4; 86.8; 88.6	—
PRIMARY Aortic Pulse Pressure	33.6; 31.8; 34.9; 32.6	—
PRIMARY Aortic Augmentation Pressure	7.4; 5.5; 6.8; 5.3	—
PRIMARY Aortic Augmentation Index for Heart Rate	14.7; 14.5; 11.9; 12.8	—
PRIMARY Pulse Wave Velocity	6.73; 5.95; 6.00; 5.78	—
PRIMARY Heart Rate, Beats Per a Minute	72.0; 75.6; 64.4; 72.1	—
SECONDARY Urinary Nitric Oxide Excretion	40.31; 61.77; 64.38; 65.54	—
SECONDARY Urinary Isoprostane Excretion	180; 165; 213; 185	—
SECONDARY Urinary Hydrogen Peroxide Excretion	0.652; 0.500; 2.79; 0.578	—
SECONDARY Plasma Interleukin Levels	1.626; 1.351; 1.647; 1.351	—

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01202175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.