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Nebivolol, Lifestyle Modification and Arterial Stiffness

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ClinicalTrials.gov Identifier: NCT01920282
Recruitment Status : Completed
First Posted : August 9, 2013
Results First Posted : March 2, 2016
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Kevin Davy, Virginia Polytechnic Institute and State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Nebivolol Other: Lifestyle Modification Other: Nebivolol plus Lifestyle Modification Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Nebivolol and Lifestyle Modification on Large Artery Stiffness in Middle-Aged and Older Hypertensive Adults
Study Start Date : January 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nebivolol
Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Drug: Nebivolol
Other Name: Bystolic

Active Comparator: Lifestyle Modification
Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists are provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein. Sodium consumption was set at 2,400 mg/day for all subjects.
Other: Lifestyle Modification
Other Names:
  • Weight loss
  • Sodium restriction
  • Physical activity

Experimental: Nebivolol plus Lifestyle Modification
Subjects begin with 5 mg/day of nebivolol and increase to 10 mg/day if brachial blood pressure is greater than 120/80 mmHg during the first 2 weeks of therapy. Subjects also receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists are provided to each individual. Individuals will be instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 min/wk of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conforms to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contains 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein with sodium consumption set at 2,400 mg/day for all subjects.
Other: Nebivolol plus Lifestyle Modification
Other Names:
  • Bsytolic
  • Weight Loss
  • Sodium restriction
  • Physical activity




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Oxidized LDL Concentration [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920282


Sponsors and Collaborators
Virginia Polytechnic Institute and State University
Forest Laboratories
Investigators
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Principal Investigator: Kevin P Davy, Ph.D. Virginia Polytechnic Institute and State University

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Responsible Party: Kevin Davy, Professor, Virginia Polytechnic Institute and State University
ClinicalTrials.gov Identifier: NCT01920282     History of Changes
Other Study ID Numbers: nebstiff
First Posted: August 9, 2013    Key Record Dates
Results First Posted: March 2, 2016
Last Update Posted: February 23, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Nebivolol
Antihypertensive Agents
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs