Nebivolol, Lifestyle Modification and Arterial Stiffness

Phase 4CompletedNCT01920282

Virginia Polytechnic Institute and State University45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Beta-stiffness Index

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.

Time frame: 12 weeks

Secondary Outcomes

Insulin Sensitivity (HOMA-IR)

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

Time frame: 12 weeks