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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

Tracking Information
First Submitted Date  ICMJE July 18, 2013
First Posted Date  ICMJE August 9, 2013
Results First Submitted Date  ICMJE December 16, 2015
Results First Posted Date  ICMJE March 2, 2016
Last Update Posted Date February 23, 2018
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
Beta-stiffness Index [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
Insulin Sensitivity (HOMA-IR) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2016)
Oxidized LDL Concentration [ Time Frame: 12 weeks ]
Original Other Pre-specified Outcome Measures
 (submitted: August 7, 2013)
  • Oxidized LDL Concentration [ Time Frame: 12 weeks ]
  • High Sensitivity C-reactive protein [ Time Frame: 12 weeks ]
  • Interleukin-6 concentration [ Time Frame: 12 weeks ]
  • Tumor necrosis factor-alpha concentration [ Time Frame: 12 weeks ]
 
Descriptive Information
Brief Title  ICMJE Nebivolol, Lifestyle Modification and Arterial Stiffness
Official Title  ICMJE Effect of Nebivolol and Lifestyle Modification on Large Artery Stiffness in Middle-Aged and Older Hypertensive Adults
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Nebivolol
    Other Name: Bystolic
  • Other: Lifestyle Modification
    Other Names:
    • Weight loss
    • Sodium restriction
    • Physical activity
  • Other: Nebivolol plus Lifestyle Modification
    Other Names:
    • Bsytolic
    • Weight Loss
    • Sodium restriction
    • Physical activity
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Nebivolol
  • 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.
    Intervention: Other: Lifestyle Modification
  • 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.
    Intervention: Other: Nebivolol plus Lifestyle Modification
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2013)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920282
Other Study ID Numbers  ICMJE nebstiff
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kevin Davy, Virginia Polytechnic Institute and State University
Study Sponsor  ICMJE Virginia Polytechnic Institute and State University
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Kevin P Davy, Ph.D. Virginia Polytechnic Institute and State University
PRS Account Virginia Polytechnic Institute and State University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP