Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function

Mercy Research

Status

Completed

Conditions

Hypertension

Treatments

Drug: Nebivolol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01056718

BYS-MD-32

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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