Trial DesignRationale and design of a randomized study to determine the value of central Blood Pressure for GUIDing managEment of hypertension: The BP GUIDE study

BackgroundNoninvasive estimates of central blood pressure (BP) predict cardiovascular morbidity and mortality independent of brachial BP. However, there are limited data on the usefulness of central BP in clinical practice. This study aims to test the value of central BP as a management tool for physicians treating patients with essential hypertension.MethodsParticipants with uncomplicated essential hypertension (N = 284) will be randomized to 12 months of treatment decisions guided by usual care (based on office, home, and 24-hour ambulatory brachial BP) or, in addition, by central BP estimated using radial tonometry (based on age- and sex-specific normal central systolic BP values). Recommendations regarding titration of antihypertensive medication (increase, decrease, or maintain dose) will be provided to each participant's general practitioner as well as the participant themselves. Relevant clinical information (eg, comorbidities, left ventricular [LV] mass, blood biochemistry, and BP-related symptoms) will be considered when making titration recommendations in all participants. The primary outcome measures will be (1) change in LV mass (by real-time 3-dimensional echocardiography), (2) amount of medication used, and (3) quality of life. Analysis will be by intention to treat.ConclusionsIt is expected that there will be no significant difference in LV mass between groups. However, it is hypothesized that there will be significantly reduced use of medication and improved quality of life in the central BP group because more appropriate titration choices will be made to maintain normal central systolic BP. Results are expected in 2012.