Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries

Study Overview
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Brief Summary
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The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.

Detailed Description
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To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

Official Title
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The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics

Conditions
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Hypertension, Diabetes

Intervention / Treatment
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* Drug: nebivolol
* Drug: Metoprolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Established Type 2 diabetic not treated with insulin Stage 1 hypertensives blood pressure > 130/80 mmHg and < 160/100 mmHg BMI < 35 Hemoglobin A1C < 8.5 Must be postmenopausal or taking some form of birth control of surgically sterile Exclusion Criteria: Acute myocardial infarction, unstable angina, stroke or TIA within the past year. Active angina in the last three months Diabetes requiring treatment with insulin Severe asthma Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception Recent history of substance or alcohol abuse . Uncontrolled hypertension systolic blood pressure >160mmHg or diastolic blood pressure > 100 mmHg

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nebivolol<br>Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached | Drug: nebivolol<br>* Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached<br>* Other names: bystolic;|
| Active Comparator: Metoprolol<br>Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached | Drug: Metoprolol<br>* Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached<br>* Other names: lopressor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central Systolic Blood Pressure (SBP) | Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure. | Baseline and 26 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pulse Wave Velocity (PWV) | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity. | Baseline and 26 Weeks | 
| Change in Augmentation Index | Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection. | Baseline and 26 Weeks | 
| Change in Pulse Pressure Amplification | To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure). | Baseline and 26 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, hypertension, aortic impedance