Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGnebivolol
nebivolol 5 or 10 mg oral, daily
Sponsors
Forest Laboratories
Jack Rubinstein
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of hypertension 2. Written informed consent before initiation of any study related procedure 3. Baseline Blood pressure \> 140 systolic or \>90 diastolic if on no antihypertensive therapy. 4. Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.
Exclusion criteria
1. Physical limitations resulting in a limited ability to walk on treadmill for stress echo 2. Intolerance to beta blockers 3. On more than one medication for the treatment of hypertension unless the second medication is a diuretic. 4. Currently pregnant or breast feeding. 5. LFT \> 3 X ULN 6. HgA1C \> 7 7. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment 8. Unwilling to follow protocol or return for study related procedures. 9. 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 10. Any other medical condition that in the PI's opinion could affect myocardial function. 11. Current ETOH or illicit drug abuse -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic and Diastolic Myocardial Function | Baseline to day 180 | Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Tolerance | Baseline to day 180. | Changes in exercise tolerance and time from baseline to 180 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | subject did not meet inclusion criteria | 1 |
Baseline characteristics
| Characteristic | Nebivolol 5 or 10 mg, Oral, Daily |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
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.
Time frame: Baseline to day 180
Population: Insufficient data to analyze.
Secondary
Exercise Tolerance
Changes in exercise tolerance and time from baseline to 180 days.
Time frame: Baseline to day 180.