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Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells

This study is currently recruiting participants.
Verified November 2012 by Emory University
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Arshed A. Quyyumi, Emory University
ClinicalTrials.gov Identifier:
NCT01041287
First received: December 29, 2009
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Nebivolol
Drug: Metoprolol succinate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells in Subjects With Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Nebivolol will improve vascular function (measured as arterial stiffness) by 1) improving markers of oxidative stress and 2) enhancing circulating EPC activity. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: December 2009
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nebivolol Drug: Nebivolol
Subjects will be randomized to either nebivolol or metoprolol succinate, and remain on the study drug for 3 months. They will then "cross over" to take 3 months of the comparator drug.
Other Name: Bystolic
Active Comparator: Toprol XL Drug: Metoprolol succinate
Subjects will be randomized to either nebivolol or metoprolol succinate, and remain on the study drug for 3 months. They will then "cross over" to take 3 months of the comparator drug.
Other Name: Toprol XL

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041287

Contacts
Contact: Nino Kavtaradze 404-712-0175 nkavtar@emory.edu
Contact: Sherri McDonald 404-712-2741 SMCDON6@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Arshed Quyyumi, MD            
Sponsors and Collaborators
Emory University
Forest Laboratories
Investigators
Principal Investigator: Arshed Quyyumi, MD Emory University
  More Information

No publications provided

Responsible Party: Arshed A. Quyyumi, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01041287     History of Changes
Other Study ID Numbers: BYD-MD-20
Study First Received: December 29, 2009
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
 Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on June 17, 2013