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NCT Number: NCT01041287

Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or post-menopausal females aged 21-80 years.
  • Hypertensive patients (BP >135/85) will be eligible to participate.
  • Patients on current anti-hypertensive therapy that does not include beta blockade should have BP >135/85.
  • Patients on anti-hypertensive therapy including beta blockade will have their beta blockers discontinued gradually over 2 weeks before enrolment.
  • 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

  • Age < 21 or >80 years
  • Initiation or change in dose of statin or anti-hypertensive therapy within 2 months before the study
  • Premenopausal females with potential for pregnancy
  • Acute infection in previous 2 weeks
  • History of substance abuse
  • Current neoplasm
  • Chronic renal failure [creatinine > 2.5 mg/dL] or liver failure (Liver enzymes >2X normal)
  • Acute coronary syndrome, Class IV heart failure, CVA, coronary intervention within 2 months
  • Known aortic stenosis, hypertrophic cardiomyopathy.
  • Inability to give informed consent
  • Inability to return to Emory for follow-up testing

Treatment and study plan

nebivolol

Drug

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

Other names: Bystolic

Metoprolol succinate

Drug

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

Other names: Toprol XL

Primary outcomes

  1. Pulse Wave Velocity (Measure of Arterial Stiffness)

    Time frame: Baseline

    The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

  2. Pulse Wave Velocity (Measure of Arterial Stiffness)

    Time frame: 3 months

    The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

  3. Pulse Wave Velocity (Measure of Arterial Stiffness)

    Time frame: 6 months

    The pulse wave velocity (PWV) system measured the velocity of the blood pressure waveform between the carotid and femoral arteries using a single-lead electrocardiogram and tonometer to measure the pressure pulse waveform sequentially at the two peripheral artery sites. PWV is calculated as PWV=distance (d)/time (t) and the unit of measure is reported as meters per second (m/s).

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells in Subjects With Hypertension

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 31, 2009
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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