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Completed

NCT Number: NCT01920282

Nebivolol, Lifestyle Modification and Arterial Stiffness

Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central arterial stiffness and these effects may contribute to improved outcomes in hypertensive patients. However, the results of several studies suggest that beta-blockers may actually increase arterial stiffness. In contrast, there is limited evidence to suggest that nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide, reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few studies have addressed this issue and all of these studies relied on indirect, blood pressure dependent measures of arterial stiffness. In addition, none of these studies focused on middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a therapy to reduce large artery stiffness, particularly among the latter population, remains unclear.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Stage 1 hypertension
  • 40-75 years
  • Weight stable (+/-2 kg)
  • Sedentary to recreationally active
  • Willing to be randomized to one of three arms
  • Verbal and written consent
  • Approval by medical director

Exclusion criteria

  • Blood pressure outside stated range
  • Diabetes or taking diabetes medications
  • Total cholesterol >6.2 mmol/L; triglycerides >4.5 mmol/L
  • Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
  • Medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements
  • Known allergy or hypersensitivity to nebivolol or any of its components
  • Inability to perform regular physical activity or participate in other components of lifestyle modification
  • Pregnant or planning to become pregnant

Treatment and study plan

nebivolol

Drug

Other names: Bystolic

lifestyle modification

Other

Other names: Weight loss, Sodium restriction, Physical activity

Nebivolol plus Lifestyle Modification

Other

Other names: Bsytolic, Weight Loss, Sodium restriction, Physical activity

Primary outcomes

  1. Beta-stiffness Index

    Time frame: 12 weeks

    Longitudinal B-mode images of the left common carotid artery diameter (1-2 cm proximal to the carotid bulb) were obtained over 15 consecutive cardiac cycles. Brachial blood pressure was measured via an automated sphygmomanometer. Quantification of systolic and diastolic carotid artery diameters were analyzed with the Vascular Research Tools 5 software program. Beta-stiffness index was calculated as: Beta = ln(P1/P0)/((D1-D0)/D0), where D0 represents the minimal diameter recorded during diastole, D1 represents the maximal diameter recorded during systole, P0 represents the pressure measured during diastole, and P1 represents the pressure measured during systole.

Secondary outcomes

  1. Insulin Sensitivity (HOMA-IR)

    Time frame: 12 weeks

    The HOMA index was calculated as the product of plasma blood glucose and insulin divided by 22.5.

Other outcomes

  1. Oxidized LDL Concentration

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

Effect of Nebivolol and Lifestyle Modification on Large Artery Stiffness in Middle-Aged and Older Hypertensive Adults

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 9, 2013
Registry last updated
Feb 23, 2018

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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