Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
James Stokes, MD, St. John's Health System, Missouri
First received: January 25, 2010
Last updated: December 17, 2013
Last verified: December 2013
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
Primary Outcome Measures:
- Improvement in LV function. [ Time Frame: Week 2, 4, and Week 10 ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
Starting on 5 mg of Nebivolol then titrated
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.
Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.
|Ages Eligible for Study:
||18 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosis (new or established) hypertension, defined by serial measurements >/= 140/90
- Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01056718
|St. John's Mercy Cardiovascular Research
|St. Louis, Missouri, United States, 63141 |
St. John's Health System, Missouri
||James A. Stokes, M.D.
||St. John's Mercy Heart & Vascular
No publications provided
||James Stokes, MD, Cardiologist Mercy Hospital, St. John's Health System, Missouri
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2010
||December 17, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 21, 2014
Adrenergic beta-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs