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2.1 Research objectives:
The objective of this randomized, placebo-controlled, 2 period crossover clinical trial is to determine the effects of nebivolol versus placebo on ambulatory blood pressure, the blood pressure response to dietary sodium loading, and renal handling of an acute sodium load in postmenopausal women with hypertension.
Nebivolol will result in a blunted response of blood pressure to oral sodium administration and improved handling of an intravenous sodium load in comparison with placebo in hypertensive postmenopausal women.
2.2 Research plan:
2.2.1 Study design
The study will consist of a randomized crossover trial of the effects on salt sensitivity of nebivolol. All study procedures will be carried out under the direct supervision of the Principal Investigator in the outpatient and inpatient research unit of the University of Miami Division of Clinical Pharmacology.
2.2.2 Primary endpoints:
1. Change and percentage change in systolic, diastolic and mean blood pressure by ABPM from final day of low sodium to the final day of high sodium in nebivolol versus placebo
2. Differences in renal sodium excretion in response to an acute sodium load during treatment with either nebivolol or placebo.
2.2.3 Secondary endpoints
1. Change in clinic blood pressure following 4 weeks of outpatient nebivolol versus placebo
2. Change in weight from final day of low sodium to the final day of high sodium in nebivolol versus placebo
3. Change in 24-hour sodium and potassium excretion from last day of low sodium to last day of high sodium
4. Asymmetrical dimethylarginine (ADMA)
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Division of Clinical Pharmacology Clinical Pharmacology Research Unit (CPRU)
1500 NW 12th Ave 15-West. Miami
Not yet recruiting
University of Miami
Published on BioPortfolio: 2014-08-27T03:18:47-0400
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