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Slow enrollment
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.
Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nebivolol 5 or 10 mg, oral, daily | Experimental | Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nebivolol | Drug | nebivolol 5 or 10 mg oral, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and Diastolic Myocardial Function | Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous. | Baseline to day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Tolerance | Changes in exercise tolerance and time from baseline to 180 days. | Baseline to day 180. |
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Inclusion Criteria:
Exclusion Criteria:
Physical limitations resulting in a limited ability to walk on treadmill for stress echo
Intolerance to beta blockers
On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
Currently pregnant or breast feeding.
LFT > 3 X ULN
HgA1C > 7
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
Unwilling to follow protocol or return for study related procedures.
Any of the following conditions:
Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction
Any other medical condition that in the PI's opinion could affect myocardial function.
Current ETOH or illicit drug abuse -
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| Name | Affiliation | Role |
|---|---|---|
| Jack Rubinstein, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nebivolol 5 or 10 mg, Oral, Daily | Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. nebivolol: nebivolol 5 or 10 mg oral, daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nebivolol 5 or 10 mg, Oral, Daily | Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. nebivolol: nebivolol 5 or 10 mg oral, daily |
| 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 | Change in Systolic and Diastolic Myocardial Function | Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous. | Insufficient data to analyze. | Posted | Baseline to day 180 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nebivolol 5 or 10 mg, Oral, Daily | Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. nebivolol: nebivolol 5 or 10 mg oral, daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jack Rubinstein | University of Cincinnati | 513-558-3062 | rubinsjk@ucmail.uc.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068577 | Nebivolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Secondary | Exercise Tolerance | Changes in exercise tolerance and time from baseline to 180 days. | Not Posted | Baseline to day 180. | Participants |
| 0 |
| 1 |
| 0 |
| 1 |
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| D000588 |
| Amines |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |