Nebivolol, Lifestyle Modification and Arterial Stiffness

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Polytechnic Institute and State University
• Collaborator: Forest Laboratories
• Treatments: Nebivolol

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