VASOTENS

Registry

PROJECT

Background

Ambulatory blood pressure, central blood pressure and pulse wave velocity are parameters indicated by current hypertension guidelines as useful for better estimating blood pressure control and vascular impairment of the hypertensive patient. Recent advances in technology made available devices allowing combined non-invasive estimation of blood pressure and arterial stiffness in ambulatory conditions over the 24-hours. However, at present, there is limited evidence on the usefulness of such an approach in the clinical practice and much has still to be done to prove its actual benefit for hypertension management.

Objective

  • Evaluation of non-invasive ambulatory blood pressure and arterial stiffness estimates (through pulse wave analysis, PWA) in hypertensive subjects undergoing an ambulatory blood pressure monitoring (ABPM) for clinical reasons in the selected centers
  • Evaluation of the changes in blood pressure and arterial stiffness estimates following treatment initiation according to current guidelines
  • Assessment of the impact of non-invasive arterial stiffness estimation on target organ damage and patient’s cardiovascular (CV) prognosis
  • Definition of the normalcy thresholds for pulse wave velocity (PWV), augmentation index (AI), and other current and future indices derived from PWA in hypertensive subjects, according to outcome data
  • Definition of the relationship between arterial stiffness, blood pressure absolute level and blood pressure variability, and outcomes
  • Setup of a worldwide network of centers performing ambulatory PWA, and validation and promotion of the use of such technique for hypertension screening and follow-up
  • Provision of evidence of the clinical relevance of non-invasive arterial stiffness assessment, in order to favor the inclusion of such evaluation in recommendations on hypertension management

Population

The registry includes data from male and female subjects (age ≥18 years) referred to routine diagnostic evaluation for hypertension, or established hypertensive subjects, in which an ABPM has been or has to be performed for clinical reasons with a BPLab device. Subjects’ data contained in existing databases collected by the participating centers and who are regularly followed-up at the center can be used. New subjects can be enrolled for this project, but they must be submitted to an ABPM because it is required for evaluating their hypertension status, according to current recommendations

Methodology

Data contained in existing electronic databases or data of newly enrolled subjects fulfilling the inclusion criteria can be uploaded/entered on the study website. These data include ABPM measures (blood pressure and arterial stiffness) obtained with a BPLab device and clinical data. ABPM data are uploaded by linking the ABPM device to a web-based telemedicine platform through a personal computer. The website includes an electronic case report form (e-CRF), allowing collection of patient’s clinical data, such as family history, anthropometric data, habits, past and current diseases (specifically including CV outcomes), therapies, office BP, and laboratory tests, including evaluation of target organ damage.

The project does not involve any type of intervention related to the study and the physicians manages the patients included in the Registry according to the requirements of clinical practice and current guidelines. However, as recommended by current guidelines, each patient is followed-up with visits occurring at regular intervals (ideally every 6 months, and not less than once a year), during which an ABPM may also be needed.

The use of the telemedicine system allows standardized and centralized data collection, data validation by experts and counselling to remote centers, setup and maintenance of the Registry.

© 2015-2018 Italian Institute of Telemedicine Frontier Theme