Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol treatment | Other | 10 week open label nebivolol treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebivolol | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Systolic BP | 10 Weeks | |
| Exercise Duration | 10 Weeks | |
| Metabolic Equivalent (METS) Level | METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival. | 10 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic BP | 10 Week | |
| Peak Stress Systolic BP | 10 Week | |
| Peak Stress Diastolic BP |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James A. Stokes, M.D. | St. John's Mercy Heart & Vascular | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Mercy Cardiovascular Research | St Louis | Missouri | 63141 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10109801 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruited from the outpatient office at Mercy St. Louis between January 2010 and August 2012. The inclusion criteria were new or established hypertension as defined by serial BP measurements greater than or equal to 140/90 and evidence of left ventricular (LV) diastolic dysfunction as defined by a routine Doppler within a year of enrollment.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol Treatment | 10 week open label nebivolol treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resting Systolic BP | Posted | Mean | Standard Deviation | mm Hg | 10 Weeks |
|
|
Patients were monitored for 10 weeks for any adverse side effects resulting in discontinuation or decrease in nebivolol dosage after the titration period. They were also monitored for cardiovascular events during the treatment period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. |
Not provided
Not provided
There was no placebo control. All patients received nebivolol and served as their own control before and after treatment. This study had a small study population and short duration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Janosik, MD | Mercy Hospital East Communities | 314-251-3920 | Denise.Janosik@mercy.net |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 10 Week |
| Resting Heart Rate | 10 Week |
| Stress Heart Rate | 10 Week |
| Resting EF | 10 Weeks |
| Stress EF | 10 Week |
| Resting Stroke Volume | 10 weeks |
| Stress Stroke Volume | 10 week |
| Resting Cardiac Output | 10 week |
| Stress Cardiac Output | 10 week |
| LV End Diastolic Diameter | 10 week |
| LV End Systolic Diameter | 10 week |
| LV Mass | 10 week |
| Mitral Valve Inflow (E) Velocity | 10 Week |
| Mitral Valve Inflow (A) Velocity | 10 Week |
| Mitral Valve E/A Ratio | mitral valve doppler E velocity to A velocity | 10 Week |
| Mitral Valve Deceleration Time | 10 Week |
| Mitral Valve Tissue Doppler Velocity (e') | 10 Week |
| Mitral Valve Tissue Doppler Velocity (a') | 10 Week |
| E/e' Ratio | 10 Week |
| Pulmonary Vein Peak Systolic Velocity | 10 Week |
| Pulmonary Vein Peak Diastolic Velocity | 10 Week |
| Quality of Life | Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the "best imaginable health state" and 0 is the "worst imaginable health state". | 10 Weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Resting Systolic BP | Mean | Standard Deviation | mm Hg |
|
| Exercise Duration | Mean | Standard Deviation | seconds |
|
| Metabolic Equivalent | One MET is defined as 3.5 mL 02 uptake/kg per minute | Mean | Standard Deviation | Mets |
|
| Resting Diastolic BP | Mean | Standard Deviation | mm Hg |
|
| Peak Stress Systolic BP | Mean | Standard Deviation | mm Hg |
|
| Peak Stress Diastolic BP | Mean | Standard Deviation | mm Hg |
|
| Resting Heart Rate | Mean | Standard Deviation | Beats per Minute |
|
| Stress Heart Rate | Mean | Standard Deviation | Beats per Minute |
|
| Resting Ejection Fraction (EF) | Ejection fraction = LV end diastolic volume - LV end systolic volume divided by LV end diastolic volume X 100 | Mean | Standard Deviation | Percent of LV end diastolic volume |
|
| Stress EF | Mean | Standard Deviation | Percent of LV end diastolic volume |
|
| Resting Stroke Volume | Mean | Standard Deviation | ml |
|
| Stress Stroke Volume | Mean | Standard Deviation | ml |
|
| Resting Cardiac Output | Mean | Standard Deviation | L per minute |
|
| Stress Cardiac Output | Mean | Standard Deviation | L per minute |
|
| LV End Diastolic Diameter | Mean | Standard Deviation | cm |
|
| LV End Systolic Diameter | Mean | Standard Deviation | cm |
|
| LV Mass | Mean | Standard Deviation | grams |
|
| Mitral Valve Inflow (E) Velocity | Mean | Standard Deviation | cm/s |
|
| Mitral Valve Inflow (A) Velocity | Mean | Standard Deviation | cm/s |
|
| Mitral Valve E/A Ratio | Mitral valve doppler E velocity to A velocity | Mean | Standard Deviation | Ratio |
|
| Mitral Valve Deceleration Time | Mean | Standard Deviation | ms |
|
| Mitral Valve Tissue Doppler Velocity (e') | Mean | Standard Deviation | cm/s |
|
| Mitral Valve Tissue Doppler Velocity (a') | Mean | Standard Deviation | cm/s |
|
| E/e' Ratio | Mitral Valve E velocity to tissue doppler e' velocity | Mean | Standard Deviation | Ratio |
|
| Pulmonary Vein Peak Systolic Velocity | Mean | Standard Deviation | cm/s |
|
| Pulmonary Vein Peak Diastolic Velocity | Mean | Standard Deviation | cm/s |
|
| Quality of Life | 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. The EuroQol, records the subject's self reported assessment of his/her overall health on a vertical, visual analogue scale where 100 is "the best imaginable health state" and 0 is the "worst imaginable health state". | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Exercise Duration | Posted | Mean | Standard Deviation | Seconds | 10 Weeks |
|
|
|
|
| Primary | Metabolic Equivalent (METS) Level | METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival. | Posted | Mean | Standard Deviation | METS | 10 Weeks |
|
|
|
|
| Secondary | Diastolic BP | Posted | Mean | Standard Deviation | mm Hg | 10 Week |
|
|
|
|
| Secondary | Peak Stress Systolic BP | Posted | Mean | Standard Deviation | mm Hg | 10 Week |
|
|
|
|
| Secondary | Peak Stress Diastolic BP | Posted | Mean | Standard Deviation | mm Hg | 10 Week |
|
|
|
|
| Secondary | Resting Heart Rate | Posted | Mean | Standard Deviation | Beats per Minute | 10 Week |
|
|
|
|
| Secondary | Stress Heart Rate | Posted | Mean | Standard Deviation | Beats per Minute | 10 Week |
|
|
|
|
| Secondary | Resting EF | Posted | Mean | Standard Deviation | Percent of LV end diastolic volume | 10 Weeks |
|
|
|
|
| Secondary | Stress EF | Posted | Mean | Standard Deviation | Percent of LV end diastolic volume | 10 Week |
|
|
|
|
| Secondary | Resting Stroke Volume | Posted | Mean | Standard Deviation | ml | 10 weeks |
|
|
|
|
| Secondary | Stress Stroke Volume | Posted | Mean | Standard Deviation | ml | 10 week |
|
|
|
|
| Secondary | Resting Cardiac Output | Posted | Mean | Standard Deviation | L per minute | 10 week |
|
|
|
|
| Secondary | Stress Cardiac Output | Posted | Mean | Standard Deviation | L per minute | 10 week |
|
|
|
|
| Secondary | LV End Diastolic Diameter | Posted | Mean | Standard Deviation | cm | 10 week |
|
|
|
|
| Secondary | LV End Systolic Diameter | Posted | Mean | Standard Deviation | cm | 10 week |
|
|
|
|
| Secondary | LV Mass | Posted | Mean | Standard Deviation | grams | 10 week |
|
|
|
|
| Secondary | Mitral Valve Inflow (E) Velocity | Posted | Mean | Standard Deviation | cm/s | 10 Week |
|
|
|
|
| Secondary | Mitral Valve Inflow (A) Velocity | Posted | Mean | Standard Deviation | cm/s | 10 Week |
|
|
|
|
| Secondary | Mitral Valve E/A Ratio | mitral valve doppler E velocity to A velocity | Posted | Mean | Standard Deviation | Ratio | 10 Week |
|
|
|
|
| Secondary | Mitral Valve Deceleration Time | Posted | Mean | Standard Deviation | ms | 10 Week |
|
|
|
|
| Secondary | Mitral Valve Tissue Doppler Velocity (e') | Posted | Mean | Standard Deviation | cm/s | 10 Week |
|
|
|
|
| Secondary | Mitral Valve Tissue Doppler Velocity (a') | Posted | Mean | Standard Deviation | cm/s | 10 Week |
|
|
|
|
| Secondary | E/e' Ratio | Posted | Mean | Standard Deviation | Ratio | 10 Week |
|
|
|
|
| Secondary | Pulmonary Vein Peak Systolic Velocity | Posted | Mean | Standard Deviation | cm/s | 10 Week |
|
|
|
|
| Secondary | Pulmonary Vein Peak Diastolic Velocity | Posted | Mean | Standard Deviation | cm/s | 10 Week |
|
|
|
|
| Secondary | Quality of Life | Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the "best imaginable health state" and 0 is the "worst imaginable health state". | Posted | Mean | Standard Deviation | units on a scale | 10 Weeks |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
Not provided
Not provided
| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |