Effect of Nebivolol on Blood Pressure in a Model of Hypertension Sensitive to Potentiation of Nitric Oxide Bioactivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure During the Night
研究概览
简要总结
The purpose of this study is to evaluate the effect of the antihypertensive drug, nebivolol (Bystolic), compared to metoprolol (Lopressor) and sildenafil (Viagra) on blood pressure in patients with autonomic failure and supine hypertension.
详细描述
Nebivolol is distinct among beta-blockers by its ability to increase nitric oxide (NO) bioactivity. The contribution of this effect to the pharmacological actions of the drug, however, is difficult to ascertain in normal subjects because of the confounding contribution of the autonomic nervous system. Autonomic failure patients provide a unique model of hypertension devoid of autonomic modulation but sensitive to NO mechanisms. We propose to determine the effect of nebivolol on blood pressure in this patient population. A decrease in blood pressure will imply increased bioactivity of NO. Comparisons will be made with placebo, metoprolol (as a negative control) and sildenafil (as a positive control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female and aged 18 years or over.
- •Clinical diagnosis of orthostatic hypotension associated with Primary Autonomic Failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).
- •A documented fall in systolic blood pressure of at least 20 mmHg, or in diastolic blood pressure of at least 10 mmHg, within 3 minutes after standing.
- •Supine hypertension, defined as a systolic blood pressure >150 mm Hg or diastolic blood pressure > 90 mm Hg.
- •Provide written informed consent to participate in the study and understand that they may withdraw their consent at any time without prejudice to their future medical care.
排除标准
- •Have changed dose, frequency and or type of prescribed medication, within two weeks of study start.
- •Women of childbearing potential who are not using a medically accepted contraception.
- •Have, in the investigator's opinion, any significant cardiac, systemic, hepatic, or renal illness.
- •Diabetes mellitus or insipidus.
- •In the investigator's opinion, have clinically significant abnormalities on clinical examination or laboratory testing.
- •In the investigator's opinion, are unable to adequately co-operate because of individual or family situation.
- •In the investigator's opinion, are suffering from a mental disorder that interferes with the diagnosis and/or with the conduct of the study, e.g. schizophrenia, major depression, dementia.
- •Are not able or willing to comply with the study requirements for the duration of the study.
- •Persons on drugs with beta-blocking potential (e.g., amiodarone), persons taking scheduled or as needed nitrates and persons on drugs with alpha-blocking potential (e.g. tamsulosin).
研究组 & 干预措施
Placebo capsule
Placebo capsule
干预措施: Placebo (Drug)
Nebivolol 5 mg
Nebivolol 5 mg capsule
干预措施: Nebivolol 5 mg (Drug)
Metoprolol tartrate 50 mg
Metoprolol tartrate 50 mg single oral dose
干预措施: metoprolol tartrate 50 mg (Drug)
Sildenafil 25 mg
Sildenafil 25 mg single oral dose
干预措施: Sildenafil25 mg (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure During the Night
时间窗: 8 pm - 8 am
Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention
次要结局
- Nocturnal Urinary Sodium Excretion(8 pm - 8 am)
- Change in Heart Rate During the Night(8 pm - 8 am)
- Orthostatic Tolerance the Following Morning(10 min standing)
研究者
Italo Biaggioni
Professor of Medicine and Pharmacology
Vanderbilt University