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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01056718
• Other study ID #: BYS-MD-32
• Status: Active, not recruiting
• Phase: N/A
• First received: January 25, 2010
• Last updated: December 17, 2013
• Start date: November 2009
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: St. John's Health System, Missouri
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Nebivolol
Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Locations

Country	Name	City	State
United States	St. John's Mercy Cardiovascular Research	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. John's Health System, Missouri	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in LV function.		Week 2, 4, and Week 10	Yes