Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Metoprolol succinate
Intervention description: Nebivolol 5 mg PO qday for 2 weeks, titrated up to Nebivolol 10 mg PO qday if BP is >125/80 for the 2 more weeks, and then titrated up to Nebivolol 20 mg PO qday if BP is >125/80 for the remaining 8 weeks; Metoprolol 50 mg PO qday for 2 weeks, titrated up to Metoprolol 100 mg PO qday if BP is >125/80 for the 2 more weeks, and then titrated up to Metoprolol 200 mg PO qday if BP is >125/80 for the remaining 8 weeks
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Hypertension, or high blood pressure, is a common disease that affects many Americans, and
      can lead to devastating consequences such as heart attack, stroke, and death if not treated.
      Nebivolol is a medication that has been recently approved by the FDA for the treatment of
      hypertension. Nebivolol has an unusual profile compared to other medications, in that its
      effects may be related to release of a substance called nitric oxide. Nitric oxide is
      released from the cells lining the blood vessels, and nebivolol may stimulate these cells to
      release more nitric oxide. Our study will investigate whether treatment with nebivolol, as
      compared to another medication called metoprolol, in hypertensive subjects will be more
      effective in protecting blood vessels against the harmful effects of high blood pressure. The
      mechanisms we will investigate include oxidative stress markers and circulating levels of
      endothelial progenitor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or post-menopausal females aged 21-80 years.

          2. Hypertensive patients (BP >135/85) will be eligible to participate.

          3. Patients on current anti-hypertensive therapy that does not include beta blockade
             should have BP >135/85.

          4. Patients on anti-hypertensive therapy including beta blockade will have their beta
             blockers discontinued gradually over 2 weeks before enrolment.

          5. Concomitant therapy: Patients will be allowed to be on comcomitant therapy with
             aspirin, statins, thiazide diuretics, calcium antagonists (for treatment of
             hypertension), clonidine, vasodilators, or angiotensin antagonists. Patients will be
             on stable medical therapy for at least 2 months before recruitment. Patients with
             previous treatment with beta adrenergic blockers (metoprolol, propranolol, atenolol,
             and labetalol) will also be eligible to participate, but will be randomized to the
             study beta blocker.

        Exclusion Criteria:

          1. Age < 21 or >80 years

          2. Initiation or change in dose of statin or anti-hypertensive therapy within 2 months
             before the study

          3. Premenopausal females with potential for pregnancy

          4. Acute infection in previous 2 weeks

          5. History of substance abuse

          6. Current neoplasm

          7. Chronic renal failure [creatinine > 2.5 mg/dL] or liver failure (Liver enzymes >2X
             normal)

          8. Acute coronary syndrome, Class IV heart failure, CVA, coronary intervention within 2
             months

          9. Known aortic stenosis, hypertrophic cardiomyopathy.

         10. Inability to give informed consent

         11. Inability to return to Emory for follow-up testing