Phase 4
Completed N=30
Nebivolol Effect on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients
Source: ClinicalTrials.gov NCT01157234 ↗Enrolled (actual)
30
Serious AEs
30.0%
Results posted
Mar 2016
Primary outcomePrimary: Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups. — 11.47; -17.27 percent change
◆ Published Evidence
Emerging
7citations · ~1 / year
Nebivolol Effects on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients.
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.
Linked Publications (2)
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Nebivolol Effects on Nitric Oxide Levels, Blood Pressure, and Renal Function in Kidney Transplant Patients.
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Antihypertensive treatment for kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Nitric Oxide Level Change From Baseline to Month 12 Between the Groups. |
11.47; -17.27 | — |
| SECONDARY Estimated Glomerular Filtration Rate (ml/Minute) Change From Baseline to Month-12 Between the Groups |
2.16; 10.43 | — |
| SECONDARY Systolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 of Treatment Between the Groups |
-2.65; -3.88 | — |
| SECONDARY Diastolic Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups |
-0.66; -2.35 | — |
| SECONDARY Mean Arterial Blood Pressure (Millimeter, Mercury) Change From Baseline to Month-12 Between the Groups |
-1.07; -3.19 | — |
| SECONDARY Number of Antihypertensive Drug Classes Change From Baseline to Month-12 Between the Groups. |
-8.14; 8.70 | — |
| SECONDARY Plasma Asymmetric Dimethylarginine (ADMA) Change From Baseline to Month 12 Between the Groups |
— | — |
| SECONDARY Plasma Arginine (ARG) Level Change From Baseline to Month-12 Between Groups |
— | — |
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) 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
Data sourced from ClinicalTrials.gov (NCT01157234) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.