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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Drug: Nebivolol; Drug: Hydrochlorothiazide

• Registration Number: NCT00999752
• Lead Sponsor: InVasc Therapeutics, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	Nebivolol	Nebivolol to reach blood pressure control
Arm B	Hydrochlorothiazide	Hydrochlorothiazide for blood pressure control

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Atlanta Vascular Research Foundation; 🇺🇸 Tucker, Georgia, United States