Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
This trial is active, not recruiting.
|Sponsor||St. John's Health System, Missouri|
|Start date||November 2009|
|End date||December 2013|
|Trial size||50 participants|
|Trial identifier||NCT01056718, BYS-MD-32|
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. In patients with predominantly diastolic heart failure it is hypothesized that by using more robust echocardiographic measures of diastolic dysfunction, significant changes will be detected. Furthermore, due to the unique properties of nebivolol it is also hypothesized that there will be improvements in LV function manifesting as increased exercise capacity as well as LVH regression as measured by echocardiography. The investigators hope to reproduce the findings shown in a prior study that showed increased stroke volume and preservation of CO in subjects receiving nebivolol.
|Intervention model||single group assignment|
Improvement in LV function.
time frame: Week 2, 4, and Week 10
Male or female participants from 18 years up to 90 years old.
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 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 NYHA heart failure symptoms - CKD 3 or greater (CrCl <30 cc/min) - Subjects with active ischemia or evidence of ischemia on initial stress echocardiography
|Official title||Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function|
|Principal investigator||James A. Stokes, M.D.|
Call for more information