Nebivolol and the Endothelin (ET)-1 System
Information source: University of Colorado, Boulder
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prehypertension; Hypertension
Intervention: Nebivolol (Drug); Metoprolol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Colorado, Boulder Official(s) and/or principal investigator(s): Christopher A DeSouza, Ph.D., Principal Investigator, Affiliation: University of Colorado at Boulder
Overall contact: Jared J Greiner, M.S., Phone: 303-735-4955, Email: jared.greiner@colorado.edu
Summary
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.
Clinical Details
Official title: Nebivolol and the Endothelin (ET)-1 System
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary outcome: ET-1-mediated vasoconstrictor tone
Detailed 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.
Eligibility
Minimum age: 45 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Jared J Greiner, M.S., Phone: 303-735-4955, Email: jared.greiner@colorado.edu
UC-Boulder Clinical and Translational Research Center, Boulder, Colorado 80309, United States; Recruiting Christopher A DeSouza, Ph.D., Principal Investigator
Additional Information
Starting date: May 2011
Last updated: December 2, 2014
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