Nebivolol and Endothelial Regulation of Fibrinolysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Heart Rate
研究概览
简要总结
The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. The investigators further hypothesize that the improvement in the capacity of the vascular endothelium to release t-PA with nebivolol is mediated, in part, by the compound's antioxidant properties.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
- •Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure >125 mmHg and <160 mmHg and/or diastolic >80 mmHg and <100 mmHg.
- •All of the women in the study will be postmenopausal and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
- •Candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.
排除标准
- •Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits).
- •Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication and aspirin) medications will not be eligible.
- •Fasting plasma glucose >126 mg/dL.
- •Potential candidates with a resting heart rate of < 50 beats/minute will be excluded.
- •Use of hormone replacement therapy.
- •In hypertensive subjects, a seated systolic blood pressure >160 mmHg or a seated diastolic blood pressure >100 mmHg will be excluded.
研究组 & 干预措施
Metoprolol
干预措施: Metoprolol (Drug)
Nebivolol
干预措施: Nebivolol (Drug)
Placebo
干预措施: Placebo (Drug)
Bradykinin
干预措施: Nebivolol (Drug)
Bradykinin
干预措施: Metoprolol (Drug)
Bradykinin
干预措施: Placebo (Drug)
Bradykinin
干预措施: Bradykinin (Other)
Saline
干预措施: Nebivolol (Drug)
Saline
干预措施: Metoprolol (Drug)
Saline
干预措施: Placebo (Drug)
Saline
干预措施: Bradykinin (Other)
Saline
干预措施: Saline (Other)
Saline
干预措施: Vitamin C (Other)
Vitamin C
干预措施: Nebivolol (Drug)
Vitamin C
干预措施: Metoprolol (Drug)
Vitamin C
干预措施: Bradykinin (Other)
Vitamin C
干预措施: Saline (Other)
Vitamin C
干预措施: Vitamin C (Other)
结局指标
主要结局
Heart Rate
时间窗: Heart rate was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Resting heart rate in the seated position
Systolic Blood Pressure
时间窗: Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Endothelial t-PA Release in Response to Bradykinin (BDK) Before and After the 12 Week Intervention
时间窗: t-PA release was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Net endothelial release of t-PA antigen in response to bradykinin (BDK) was calculated using the following equation: Net Release of t-PA Antigen=(Cv-Ca) x (FBF x \[101-hematocrit/100\]) where Cv and Ca represent the concentration of t-PA in the vein and artery respectively. A positive difference indicates a net release and a negative difference net uptake. Arterial and venous blood samples are collected simultaneously at baseline and each dose of the drug (BDK). t-PA concentration were determined by enzyme immunoassay. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the trapped red blood cells.
Endothelial t-PA Release in Response to Bradykinin (BDK) and Bradykinin+Vitamin C (BDK+C) Before and After 12 Weeks of Nebivolol Therapy.
时间窗: t-PA release was measured before the 12 week drug intervention and after the 12 week drug intervention.
Net endothelial release of t-PA antigen in response to bradykinin (BDK) and bradykinin+vitamin C (BDK+C) was calculated using the following equation: Net Release of t-PA Antigen=(Cv-Ca) x (FBF x \[101-hematocrit/100\]) where Cv and Ca represent the concentration of t-PA in the vein and artery respectively. A positive difference indicates a net release and a negative difference net uptake. Arterial and venous blood samples are collected simultaneously at baseline and each dose of the drug (BDK) and BDK+Vit C. t-PA concentration were determined by enzyme immunoassay. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the trapped red blood cells.
Diastolic Blood Pressure
时间窗: Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
Endothelial t-PA Release in Response to BDK and BDK+C Before and After 12 Weeks of Metoprolol Therapy.
时间窗: t-PA release was measured before the 12 week drug intervention and after the 12 week drug intervention.
Net endothelial release of t-PA antigen in response to BDK and BDK+C was calculated using the following equation: Net Release of t-PA Antigen=(Cv-Ca) x (FBF x \[101-hematocrit/100\]) where Cv and Ca represent the concentration of t-PA in the vein and artery respectively. A positive difference indicates a net release and a negative difference net uptake. Arterial and venous blood samples are collected simultaneously at baseline and each dose of the drug (BDK) and BDK+Vit C. t-PA concentration were determined by enzyme immunoassay. Hematocrit was measured in triplicate using the standard microhematocrit technique and corrected for trapped plasma volume within the trapped red blood cells.
次要结局
未报告次要终点
研究者
Christopher DeSouza
Professor
University of Colorado, Boulder