An Advanced Echocardiographic Evaluation of Nebivolol

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

nebivolol

Intervention Type DRUG

nebivolol 5 or 10 mg oral, daily

Interventions

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nebivolol

nebivolol 5 or 10 mg oral, daily

Intervention Type DRUG

Other Intervention Names

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Bystolic

Eligibility Criteria

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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 -

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No