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

Abstract

BackgroundHypertension guidelines recommend ambulatory blood pressure (ABP), central aortic pressure (CAP), and pulse wave velocity (PWV) as parameters for estimating blood pressure (BP) control and vascular impairment. Recent advances in technology 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.ObjectiveWe recently launched an investigator-initiated, international, multicenter, observational, prospective study, the Vascular health Assessment Of The Hypertensive patients (VASOTENS) Registry, aimed at (1) evaluating non-invasive 24-hour ABP and arterial stiffness estimates (through 24-hour pulse wave analysis, PWA) in hypertensive subjects undergoing ambulatory blood 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 arterial stiffness, 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.MethodsApproximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up of hypertension of any severity or stage, will be recruited. Data collection will include ABPM, performed with a device allowing simultaneous non-invasive assessment of 24-hour CAP and arterial stiffness (BPLab), and clinical data (including cardiovascular outcomes). 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 data collection, data validation by experts and counseling to remote centers, setup and maintenance of the Registry, and prompt data analysis.ResultsFirst follow-up results are expected to be available in the next 2 years.ConclusionsThe results of the VASOTENS Registry will help define the normalcy thresholds for current and future indices derived from 24-hour PWA, according to outcome data, and will also provide supporting evidence for the inclusion of this type of evaluation in hypertension management.Trial registrationClinicaltrials.gov NCT02577835; https://clinicaltrials.gov/ct2/show/NCT02577835 (Archived by WebCite at http://www.Webcitation.org/6hzZBKY2Q)

Ambulatory blood pressure and arterial stiffness web‐based telemonitoring in patients at cardiovascular risk. First results of the VASOTENS (Vascular health ASsessment Of The hypertENSive patients) Registry

“…The trial is registered with ClinicalTrials.gov at number NCT02577835. A total of 24 hypertension centers worldwide were involved in the study (12 in Russia, 2 in Italy, 2 in Argentina, 2 in Portugal, 1 in Australia, 1 in Mexico, 1 in Romania, 1 in Ukraine, 1 in Kazakhstan, and 1 in Armenia), of which 16 actively recruited male or female adult participants (age ≥ 18 years) referred to the study centers for routine diagnostic evaluation of a suspected hypertension or with established hypertension of any severity or stage, and requiring an ABPM for evaluating their condition, according to current recommendations . Participants could not be enrolled in case of atrial fibrillation, frequent ectopic beats, second‐ or third‐degree atrioventricular blocks, or other conditions which might have made difficult or unreliable the automatic BP measurement with the oscillometric technique.…”

“…CAP was estimated relative to measured brachial SBP and DBP, as common for other type I devices. A detailed description of the methodology may be found elsewhere . The accuracy of the BPLab device for the assessment of vascular indices has been validated in studies against non‐invasive measurements of the same parameters obtained with the Sphygmocor device …”

“…[5][6][7] As detailed in the publication relative to the study protocol, the VASOTENS (Vascular health ASsessment Of The hypertENSive patients) Registry has several objectives, including the evaluation of clinical usefulness of 24-hour measures of vascular biomarkers, their changes following treatment, and their impact on hypertension-mediated organ damage and CV prognosis. 5 The novelty of the project is that data collection is made through a telehealth solution which ensures standardized and centralized data collection, prompt data validation and analysis, effective study monitoring and auditing, easy and real-time distribution of software updates and bug corrections. Ultimately, the international nature of the study coupled with the telemonitoring tool may help foster the implementation of an advanced screening option for patients with hypertension or at risk for CV disease through a worldwide network of expert centers linked together through telehealth.…”

“…requiring an ABPM for evaluating their condition, according to current recommendations 5. Participants could not be enrolled in case of atrial fibrillation, frequent ectopic beats, second-or thirddegree atrioventricular blocks, or other conditions which might have made difficult or unreliable the automatic BP measurement with the oscillometric technique.…”

The relationships between lipid ratios and arterial stiffness

“…New instruments, using an oscillometric technique and a procedure that takes only 2 to 3 minutes, seem to offer a solution allowing estimation of aortic PWV by using a simple upper arm cuff . Some of these devices have versions developed for 24‐hour blood pressure and arterial stiffness monitoring, opening a new field of research interest . Even if some of these methods provide PWV values very close to those recorded by widely accepted and clinically validated devices or by invasive techniques, none of these new methods are currently recommended by any scientific society as an alternative to cfPWV because there is limited evidence of cardiovascular outcome prediction in longitudinal studies …”