The goal of this pilot study is to effectively treat hypertension in subjects with either known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due to the unique properties of nebivolol, it is hypothesized that there will be improvements in left ventricular (LV) systolic and diastolic function manifesting as increase exercise capacity in this patient population with primarily LV diastolic dysfunction. The present study was performed to determine the effects of nebivolol on blood pressure, exercise tolerance and parameters of left ventricular systolic and diastolic function in a group of hypertensive patients with echocardiographic evidence diastolic dysfunction.
Prior to the initiation of Nebivolol and after 10 weeks of Nebivolol therapy, subjects underwent a resting 2D echocardiogram including routine sampling of mitral valve (MV) inflow and LV tissue Doppler imaging as well as a symptom limited exercise treadmill stress test with echocardiographic imaging. Primary endpoints were 1) changes in systolic blood pressure before and after 10 weeks of treatment and 2) changes in exercise capacity as determined by exercise duration and metabolic equivalent (MET) level before and after treatment. Secondary endpoints were changes in exercise hemodynamics and Doppler echocardiographic parameters of LV systolic and diastolic function and quality of life before and after 10 weeks of nebivolol treatment. Subjects completed an EuroQol (EQ-SD) Quality of Life questionnaire which is a standardized measure of health status developed by the EuroQol group as a simple general measure of health at baseline and at conclusion of the 10 week trial period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. The dose was titrated by doubling the previous dosage to achieve BP less than or equal to 130/80 mm Hg at 2 weeks and 4 weeks. The mean dose of nebivolol used week 4 through week 10 was 7.8 mg. It should be noted that nebivolol was added to the subject's existing stable antihypertensive regimen which included a mean of 2 other medications.
St. John's Mercy Cardiovascular Research
St Louis, Missouri, United States
Resting Systolic BP
Time frame: 10 Weeks
Exercise Duration
Time frame: 10 Weeks
Metabolic Equivalent (METS) Level
METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.
Time frame: 10 Weeks
Diastolic BP
Time frame: 10 Week
Peak Stress Systolic BP
Time frame: 10 Week
Peak Stress Diastolic BP
Time frame: 10 Week
Resting Heart Rate
Time frame: 10 Week
Stress Heart Rate
Time frame: 10 Week
Resting EF
Time frame: 10 Weeks
Stress EF
Time frame: 10 Week
Resting Stroke Volume
Time frame: 10 weeks
Stress Stroke Volume
Time frame: 10 week
Resting Cardiac Output
Time frame: 10 week
Stress Cardiac Output
Time frame: 10 week
LV End Diastolic Diameter
Time frame: 10 week
LV End Systolic Diameter
Time frame: 10 week
LV Mass
Time frame: 10 week
Mitral Valve Inflow (E) Velocity
Time frame: 10 Week
Mitral Valve Inflow (A) Velocity
Time frame: 10 Week
Mitral Valve E/A Ratio
mitral valve doppler E velocity to A velocity
Time frame: 10 Week
Mitral Valve Deceleration Time
Time frame: 10 Week
Mitral Valve Tissue Doppler Velocity (e')
Time frame: 10 Week
Mitral Valve Tissue Doppler Velocity (a')
Time frame: 10 Week
E/e' Ratio
Time frame: 10 Week
Pulmonary Vein Peak Systolic Velocity
Time frame: 10 Week
Pulmonary Vein Peak Diastolic Velocity
Time frame: 10 Week
Quality of Life
Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the "best imaginable health state" and 0 is the "worst imaginable health state".
Time frame: 10 Weeks
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