Nebivolol and the Endothelin (ET)-1 System
This trial is active, not recruiting.
|Treatments||nebivolol, metoprolol, placebo|
|Sponsor||University of Colorado, Boulder|
|Start date||May 2011|
|End date||December 2016|
|Trial size||48 participants|
|Trial identifier||NCT01395329, BYS-MD-57|
The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.
|Endpoint classification||pharmacodynamics study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
ET-1-mediated vasoconstrictor tone
time frame: Forearm blood flow will be measured at week 3 (before the 12 week drug or placebo intervention) and at week 15 (after the 12 week drug or placebo intervention).
Male or female participants from 45 years up to 65 years old.
- 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 >130 mmHg and < 160 mm Hg and/or diastolic blood pressure >80 mmHg and < 100 mm Hg.
- All of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
- Lastly, 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.
- 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 an 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 greater than 160 mmHg or a seated diastolic blood pressure greater than 100 mmHg.
|Official title||Nebivolol and the Endothelin (ET)-1 System|
|Principal investigator||Christopher A DeSouza, Ph.D.|
|Description||1. The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. 2. The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.|
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