Vascular Health Assessment of The Hypertensive Patients (VASOTENS) Registry: Study Protocol of an International, Web-Based Telemonitoring Registry for Ambulatory Blood Pressure and Arterial Stiffness

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Abstract

Background: Hypertension guidelines recommend ambulatory blood pressure (ABP), central aortic pressure (CAP), and pulsewave velocity (PWV) as parameters for estimating blood pressure (BP) control and vascular impairment. Recent advances intechnology have enabled devices to combine non-invasive estimation of these parameters over the 24-hour ABP monitoring.However, currently there is limited evidence on the usefulness of such an approach for routine hypertension management.Objective: We recently launched an investigator-initiated, international, multicenter, observational, prospective study, theVascular health Assessment Of The Hypertensive patients (VASOTENS) Registry, aimed at (1) evaluating non-invasive 24-hourABP and arterial stiffness estimates (through 24-hour pulse wave analysis, PWA) in hypertensive subjects undergoing ambulatoryblood pressure monitoring (ABPM) for clinical reasons; (2) assessing the changes in estimates following treatment; (3) weighing the impact of 24-hour PWA on target organ damage and cardiovascular prognosis; (4) assessing the relationship between arterialstiffness, BP absolute mean level and variability, and prognosis; and (5) validating the use of a 24-hour PWA electronic health(e-health) solution for hypertension screening.Methods: Approximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up ofhypertension of any severity or stage, will be recruited. Data collection will include ABPM, performed with a device allowingsimultaneous non-invasive assessment of 24-hour CAP and arterial stiffness (BPLab), and clinical data (including cardiovascularoutcomes). As recommended by current guidelines, each patient will be followed-up with visits occurring at regular intervals(ideally every 6 months, and not less than once a year depending on disease severity). A Web-based telemedicine platform(THOLOMEUS) will be used for data collection. The use of the telemedicine system will allow standardized and centralized datacollection, data validation by experts and counseling to remote centers, setup and maintenance of the Registry, and prompt dataanalysis.Results: First follow-up results are expected to be available in the next 2 years.Conclusions: The results of the VASOTENS Registry will help define the normalcy thresholds for current and future indicesderived from 24-hour PWA, according to outcome data, and will also provide supporting evidence for the inclusion of this typeof evaluation in hypertension management.
Lingua originaleEnglish
pagine (da-a)e137-
Numero di pagine12
RivistaJMIR RESEARCH PROTOCOLS
Volume5
Stato di pubblicazionePublished - 2016

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