Clinical trial NCT01056718: Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
Official title: Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Diastolic Function
Nebivolol
Lead sponsor: Mercy Research
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2010-01-26
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Resting Systolic BP
timeFrame: 10 Weeks
measure: Exercise Duration
timeFrame: 10 Weeks
measure: Metabolic Equivalent (METS) Level
timeFrame: 10 Weeks
Secondary outcomes:
measure: Diastolic BP
timeFrame: 10 Week
measure: Peak Stress Systolic BP
timeFrame: 10 Week
measure: Peak Stress Diastolic BP
timeFrame: 10 Week
measure: Resting Heart Rate
timeFrame: 10 Week
measure: Stress Heart Rate
timeFrame: 10 Week
measure: Resting EF
timeFrame: 10 Weeks
measure: Stress EF
timeFrame: 10 Week
measure: Resting Stroke Volume
timeFrame: 10 weeks
measure: Stress Stroke Volume
timeFrame: 10 week
measure: Resting Cardiac Output
timeFrame: 10 week
measure: Stress Cardiac Output
timeFrame: 10 week
measure: LV End Diastolic Diameter
timeFrame: 10 week
measure: LV End Systolic Diameter
timeFrame: 10 week
measure: LV Mass
timeFrame: 10 week
measure: Mitral Valve Inflow (E) Velocity
timeFrame: 10 Week
measure: Mitral Valve Inflow (A) Velocity
timeFrame: 10 Week
measure: Mitral Valve E/A Ratio
timeFrame: 10 Week
measure: Mitral Valve Deceleration Time
timeFrame: 10 Week
measure: Mitral Valve Tissue Doppler Velocity (e')
timeFrame: 10 Week
measure: Mitral Valve Tissue Doppler Velocity (a')
timeFrame: 10 Week
measure: E/e' Ratio
timeFrame: 10 Week
measure: Pulmonary Vein Peak Systolic Velocity
timeFrame: 10 Week
measure: Pulmonary Vein Peak Diastolic Velocity
timeFrame: 10 Week
measure: Quality of Life
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: St. John's Mercy Cardiovascular Research
state: Missouri
Study officials:
affiliation: St. John's Mercy Heart & Vascular
name: James A. Stokes, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.