Overview

This trial is active, not recruiting.

Condition hypertension
Treatment nebivolol
Sponsor St. John's Health System, Missouri
Collaborator Forest Laboratories
Start date November 2009
End date December 2013
Trial size 50 participants
Trial identifier NCT01056718, BYS-MD-32

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.
nebivolol
Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Primary Outcomes

Measure
Improvement in LV function.
time frame: Week 2, 4, and Week 10

Eligibility Criteria

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

Additional Information

Official title Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
Principal investigator James A. Stokes, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by St. John's Health System, Missouri.