Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the effects of Nebivolol and Hydrochlorothiazide on blood pressure in African Americans with high blood pressure.

Detailed Description
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Many blood pressure medications are not effective in African American men and women. The two lower chambers of the heart contract to pump blood to the body. The lower chambers have to relax so they can refill with blood to pump out again. Many patients with high blood pressure have stiffness in the lower chambers which prevents the heart from relaxing so it can properly fill with blood. Some patients with the stiffness in the lower chambers of the heart will develop heart failure. The study is to test whether or not Nebivolol (Bystolic)and a diuretic Hydrochlorothiazide (HCTZ) will help the heart relax so the heart can properly fill and prevent stiffness of the lower heart chambers.

Official Title
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A 25 Week, Open Label Study to Determine the Effects of Nebivolol When Added to Hydrochlorothiazide on Diastolic Function and Arterial Stiffness in African Americans With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Nebivolol
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known Hypertension by history Self-described African American Exclusion Criteria: Uncontrolled Diabetes Mellitus (HbA1C>10) Known CAD, Cerebrovascular Disease, PVD or Renovascular Disease Liver disease Chronic Renal Disease Uncontrolled Hypertension (>199 systolic and/or >115)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Nebivolol to reach blood pressure control | Drug: Nebivolol<br>* 5mg/day with increase to 10 mg/day to reach blood pressure <140/90<br>* Other names: Bystolic;|
| Active Comparator: Arm B<br>Hydrochlorothiazide for blood pressure control | Drug: Hydrochlorothiazide<br>* Hydrochlorothiazide 25 mg/day<br>* Other names: HCTZ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90 |  | Every visit for 25 weeks (9 study visits) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences after nebivolol treatment on diastolic function as measured by tissue doppler imaging (ECHO), arterial compliance and stiffness and vascular nitric oxide availability determined by neutrophil function |  | At the begining and end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, African Americans, Arterial Stiffness, Vascular Resistance