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Completed

NCT Number: NCT00999752

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Vascular Research Foundation

Tucker, Georgia, 30084, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

nebivolol

Drug

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

Other names: Bystolic

Hydrochlorothiazide

Drug

Hydrochlorothiazide 25 mg/day

Other names: HCTZ

Primary outcomes

  1. Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90

    Time frame: Every visit for 25 weeks (9 study visits)

Secondary outcomes

  1. 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

    Time frame: At the begining and end of study

Sponsors and collaborators

Lead sponsor

InVasc Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: NASAA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2009
Registry last updated
May 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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