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

NCT ID: NCT01056718

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nebivolol treatment

10 week open label nebivolol treatment.

Group Type: OTHER

Nebivolol

Intervention Type: DRUG

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.

Interventions

Nebivolol

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Forest Laboratories

INDUSTRY

Sponsor Role: collaborator

Mercy Research

OTHER

Sponsor Role: lead

Responsible Party

James Stokes, MD

Cardiologist Mercy Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James A. Stokes, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. John's Mercy Heart & Vascular

Locations

St. John's Mercy Cardiovascular Research

St Louis, Missouri, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 10109801 (View on PubMed)

Other Identifiers

BYS-MD-32

Identifier Type: -

Identifier Source: org_study_id