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.

University of California, San Diego1 个研究点分布在 1 个国家目标入组 50 人开始时间: 2010年7月最近更新: 2019年8月21日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: University of California, San Diego
入组人数: 50
试验地点: 1
主要终点: Aortic Diastolic Blood Pressure (DBP)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•• 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.

排除标准

•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.

研究组 & 干预措施

Nebivolol

Experimental

干预措施: Nebivolol (Drug)

Sugar pill

Placebo Comparator

干预措施: Nebivolol (Drug)