Study to Determine the Effects of Nebivolol and Hydrochlorothiazide in African Americans With Hypertension
Information source: InVasc Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Nebivolol (Drug); Hydrochlorothiazide (Drug)
Phase: N/A
Status: Completed
Sponsored by: InVasc Therapeutics, Inc. Official(s) and/or principal investigator(s): Bobby V Khan, MD PhD, Principal Investigator, Affiliation: InVasc Therapeutics, Inc.
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.
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Changes in systolic and diastolic blood pressure after treatment with nebivolol and reaching normal blood pressure <140/90
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Atlanta Vascular Research Foundation, Tucker, Georgia 30084, United States
Additional Information
Starting date: October 2009
Last updated: May 4, 2011
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