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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00999752

Acronym

NASAA

Enrollment

Registered

2009-10-22

Start date

2009-10-31

Completion date

2010-05-31

Last updated

2011-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, African Americans, Arterial Stiffness, Vascular Resistance

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.

Interventions

DRUGNebivolol

5mg/day with increase to 10 mg/day to reach blood pressure \<140/90

DRUGHydrochlorothiazide

Hydrochlorothiazide 25 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026