Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | November 2009 |
| End Date: | May 2014 |
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.
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.
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.
Inclusion Criteria:
- Diagnosis (new or established) hypertension, defined by serial measurements >/=
140/90
- Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler
Exclusion Criteria:
- Severe bronchospastic disease/ reactive airway disease
- Inability to tolerate beta blocker therapy including: >1st degree atrioventricular
(AV) block, symptomatic hypotension, symptomatic bradycardia,
- Subjects with physical limitations that would prevent them from participating in an
exercise treadmill test
- Age <18 or >90 years
- Those with life expectancy <1 year
- Subjects with class III/IV New York Heart Association (NYHA) heart failure symptoms
- Chronic Kidney Disease 3 or greater (CrCl <30 cc/min)
- Subjects with active ischemia or evidence of ischemia on initial stress
echocardiography
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