Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol; Metoprolol
Intervention description: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90.; Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90.
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension; Kidney transplantation; Renal function; Nitric Oxide; Nebivolol

Summary:

      This study will investigate the blood pressure lowering efficacy of nebivolol among renal
      transplant recipients who are on calcineurin inhibitors which are believed to contribute to
      hypertension by sympathetic nervous system (SNS) activation and decreased prostaglandin and
      nitric oxide production. Hypotheses:

        1. There is a significant difference in the effect of 12 months of Nebivolol versus
           Metoprolol treatment on the plasma nitric oxide level of hypertensive renal transplant
           patients.

        2. There is a significant difference in the effect of 12 months of Nebivolol versus
           Metoprolol treatment on the estimated glomerular filtration rate of hypertensive renal
           transplant patients.

        3. There is a significant difference in the effect of 12 months of Nebivolol versus
           Metoprolol treatment on the systolic, diastolic and mean arterial blood pressures of
           hypertensive renal transplant patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women at least 18 years of age who are recipients of - a solitary kidney or
             combined kidney-pancreas transplant within the last twenty four months

          -  Current diagnosis of hypertension

          -  Normal hepatic enzymes

          -  Estimated creatinine clearance (by cockcroft-gault formula) >or= 30 ml/min

        Exclusion Criteria:

          -  Any contraindication to taking beta-blockers, specifically Nebivolol or Metoprolol.
             Conditions such as : (bradycardia heart rate (HR) <60 beats per minute , heart block >
             1st degree, decompensated cardiac failure, sick sinus syndrome (unless permanent
             pacemaker in place), severe hepatic impairment( defined as elevation of aspartamine
             aminotransferase , alanine aminotransferase, or bilirubin levels to three times upper
             limit of normal reference range), severe peripheral arterial circulatory disorder,
             history of bronchospasm and /or asthma and /or regular medication with inhaled
             bronchodilators. or , or any medical condition that in the opinion of the investigator
             may interfere with the subject's ability to successfully complete the protocol.

          -  Any medical condition which, in the opinion of the Principal Investigator, might
             compromise the safety of the subject in participating in the protocol such as
             hypotension or not requiring antihypertensive medications.

          -  Any serious systemic disease that might complicate management and reduce life
             expectancy.

          -  Uncontrolled hypertension defined as systolic blood pressure (SBP) > 210 or diastolic
             blood pressure (DBP) > 120 mm Hg.

          -  Symptomatic hypotension

          -  Previous intolerance to beta blockers

          -  Cerebrovascular accident within 3 months of randomization