N/A
N=53
Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01056718 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Resting Systolic BP — 135 mm Hg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nebivolol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mercy Research
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting Systolic BP |
135 | <0.05 sig |
| PRIMARY Exercise Duration |
419 | <0.05 sig |
| PRIMARY Metabolic Equivalent (METS) Level |
6.7 | <0.05 sig |
| SECONDARY Diastolic BP |
76 | =.078 |
| SECONDARY Peak Stress Systolic BP |
171 | =.186 |
| SECONDARY Peak Stress Diastolic BP |
68 | <0.05 sig |
| SECONDARY Resting Heart Rate |
65 | <0.05 sig |
| SECONDARY Stress Heart Rate |
118 | =0.06 |
| SECONDARY Resting EF |
63 | <0.05 sig |
| SECONDARY Stress EF |
72 | <0.05 sig |
| SECONDARY Resting Stroke Volume |
48 | =0.85 |
| SECONDARY Stress Stroke Volume |
51 | =0.40 |
| SECONDARY Resting Cardiac Output |
3.0 | =0.64 |
| SECONDARY Stress Cardiac Output |
5.3 | =0.49 |
| SECONDARY LV End Diastolic Diameter |
4.8 | =0.47 |
| SECONDARY LV End Systolic Diameter |
3.1 | =0.55 |
| SECONDARY LV Mass |
167 | =0.64 |
| SECONDARY Mitral Valve Inflow (E) Velocity |
85 | <0.05 sig |
| SECONDARY Mitral Valve Inflow (A) Velocity |
90 | =.526 |
| SECONDARY Mitral Valve E/A Ratio |
0.97 | <0.05 sig |
| SECONDARY Mitral Valve Deceleration Time |
227 | =.925 |
| SECONDARY Mitral Valve Tissue Doppler Velocity (e') |
8.7 | <0.05 sig |
| SECONDARY Mitral Valve Tissue Doppler Velocity (a') |
11.5 | =.458 |
| SECONDARY E/e' Ratio |
10.5 | =.561 |
| SECONDARY Pulmonary Vein Peak Systolic Velocity |
63 | =.734 |
| SECONDARY Pulmonary Vein Peak Diastolic Velocity |
51 | =.129 |
| SECONDARY Quality of Life |
78 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01056718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.