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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
20
Placebo capsule
Nebivolol 5mg single oral dose
metoprolol tartrate 50 mg single oral dose
Vanderbilt University
Nashville, Tennessee, United States
Change in Systolic Blood Pressure During the Night
Maximal change from baseline in systolic blood pressure, measured from 8 pm to 8 am, after a single dose of the intervention
Time frame: 8 pm - 8 am
Nocturnal Urinary Sodium Excretion
Nocturnal sodium excretion was defined as the ratio of urinary sodium to urinary creatinine.
Time frame: 8 pm - 8 am
Orthostatic Tolerance the Following Morning
Orthostatic tolerance was defined as the area under the curve of standing systolic blood pressure calculated by the trapezoidal rule (upright systolic blood pressure multiplied by standing time) during a 10-minute standing test
Time frame: 10 min standing
Change in Heart Rate During the Night
Change from baseline (8 pm) in heart rate at the time of maximal BP-lowering effect
Time frame: 8 pm - 8 am
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Sildenafil 25 mg single oral dose