International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring (VASOTENS)

• ClinicalTrials.gov Identifier: NCT02577835
• Recruitment Status: Unknown
• First Posted: October 16, 2015
• Last Update Posted: February 15, 2021
• Sponsor: Italian Institute of Telemedicine
• Collaborator: BPLab
• Information provided by (Responsible Party): Italian Institute of Telemedicine

Tracking Information

• First Submitted Date: October 13, 2015
• First Posted Date: October 16, 2015
• Last Update Posted Date: February 15, 2021
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 11, 2021)

• 24-hour Pulse Wave Velocity (PWV) [ Time Frame: 2 years ]
  24-hour average value for arterial stifness (m/s)
• 24-hour Augmentation Index (AI) [ Time Frame: 2 years ]
  24-hour average value for waves reflection (percent)
• 24-hour Central Blood Pressure [ Time Frame: 2 years ]
  24-hour average central aortic pressure (mmHg)

Original Primary Outcome Measures (submitted: October 14, 2015)

• 24-hour Pulse Wave Velocity (PWV) [ Time Frame: 2 years ]
• 24-hour Augmentation Index (AI) [ Time Frame: 2 years ]
• 24-hour Central Blood Pressure [ Time Frame: 2 years ]

Current Secondary Outcome Measures (submitted: February 9, 2021)

• 24-hour Systolic Blood Pressure [ Time Frame: 2 years ]
  Average 24-hour brachial systolic blood pressure (mmHg)
• 24-hour Diastolic Blood Pressure [ Time Frame: 2 years ]
  Average 24-hour brachial diastolic blood pressure (mmHg)
• 24-hour Systolic and Diastolic Blood Pressure standard deviation [ Time Frame: 2 years ]
  A measure of blood pressure variability (mmHg)
• 24-hour Systolic and Diastolic Blood Pressure weighted standard deviation [ Time Frame: 2 years ]
  A measure of blood pressure variability (mmHg)
• 24-hour Systolic and Diastolic Blood Pressure average real variability [ Time Frame: 2 years ]
  A measure of blood pressure variability (mmHg)
• Cardiac Damage (left ventricular hypertrophy at echocardiogram or ECG) [ Time Frame: 2 years ]
  Left ventricular hypertrophy indexed by body surface area (g/m^2)
• Vascular Damage (carotid plaque at ultrasonography) [ Time Frame: 2 years ]
  Intima media tickness (mmm)
• Renal damage (urine protein) [ Time Frame: 2 years ]
  Urine proteine (mg/24h)
• Cardiovascular fatal and non fatal events [ Time Frame: 2 years ]
  Cardiovascular outcomes

Original Secondary Outcome Measures (submitted: October 14, 2015)

• 24-hour Systolic Blood Pressure [ Time Frame: 2 years ]
• 24-hour Diastolic Blood Pressure [ Time Frame: 2 years ]
• 24-hour Systolic and Diastolic Blood Pressure standard deviation [ Time Frame: 2 years ]
  A measure of blood pressure variability
• 24-hour Systolic and Diastolic Blood Pressure weighted standard deviation [ Time Frame: 2 years ]
  A measure of blood pressure variability
• 24-hour Systolic and Diastolic Blood Pressure average real variability [ Time Frame: 2 years ]
  A measure of blood pressure variability
• Cardiac Damage (left ventricular hypertrophy at echocardiogram or ECG) [ Time Frame: 2 years ]
• Vascular Damage (carotid plaque at ultrasonography) [ Time Frame: 2 years ]
• Renal damage (urine protein) [ Time Frame: 2 years ]
• Cardiovascular fatal and non fatal events [ Time Frame: 2 years ]
  Cardiovascular outcomes

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
• Official Title: International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
• Brief Summary: This Registry is an investigator-initiated, international, multicenter, observational, prospective study aiming at: i) evaluating non-invasive 24-h ambulatory blood pressure and arterial stiffness estimates (through 24-h pulse wave analysis) in hypertensive subjects; ii) assessing the changes in estimates following treatment; iii) weighing the impact of 24-h pulse wave analysis on target organ damage and cardiovascular prognosis; iv) assessing the relationship between arterial stiffness, blood pressure absolute level and variability, and prognosis. Approximately 2000 subjects, referred to 20 hypertension clinics for routine diagnostic evaluation and follow-up of hypertension, will be recruited. Data collection will include ambulatory blood pressure monitoring, performed with a device allowing simultaneous non-invasive assessment of blood pressure and arterial stiffness, and clinical data (including cardiovascular outcomes). A web-based telemedicine platform will be used for data collection. Subjects will visit the centers at 6-12 month intervals. First follow-up results are expected to be available in the next 2-years. The results of the Registry will help defining the normalcy thresholds for current and future indices derived from 24-h pulse wave velocity, according to outcome data. They will also provide supporting evidence for the inclusion of such evaluation in recommendations on hypertension management.
• Detailed Description: The VASOTENS Registry is an international, multicenter, observational, prospective project Actually, it is a large database of ambulatory blood pressure recordings obtained with a non-invasive device, able to determine central blood pressure and various indices of arterial stiffness (mainly pulse wave velocity and augmentation index) over the 24-hours, based on a clinically validated technology of pulse wave analysis of oscillometric blood pressure measurements, integrated in an ambulatory blood pressure monitor. Specifically, this project aims at creating an international network of centers performing ambulatory blood pressure monitoring and arterial stiffness monitoring, in order to evaluate the impact of such estimates on the clinical outcome of hypertensive patients. The results of the data collected at baseline and during regular follow-up of hypertensive patients (up to 2 years) will help to provide evidence on the clinical usefulness of such technologies for the screening and follow-up of the hypertensive patients. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambulatory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Data collection is ensured by a dedicated web-based telemedicine platform, including an electronic case report form (e-CRF). The e-CRF allows collection of patient's clinical data, such as family history, anthropometric data, habits, past and current diseases, therapies, office blood pressure, 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 can manage the patients included in the Registry according to the requirements of clinical practice and current guidelines. However, as recommended by current guidelines, each patient has to be followed-up with visits occurring at regular intervals (ideally every 6 months, and not less than once a year). The physicians is also free to use the ambulatory blood pressure data in the clinical management of the patients. At least 30 Hypertension centers are planned to be involved in the project, each one providing at least 100 patients, which have to be followed-up over time. Centers will be selected in different countries, initially in Europe, starting from Italy and Russia. Mandatory criteria of a center to be included in the study are the availability in the facility of a BPLab ambulatory blood pressure monitor, the potential for providing and properly following-up the number of patients required by the protocol, the availability of Internet connection, regular access to the web and human resources to upload ambulatory blood pressure and clinical data.
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 2 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Suspected hypertensive patients referred to routine diagnostic evaluation for their condition (hypertension) or established hypertensive subjects
• Condition: Hypertension

Intervention

Device: Ambulatory blood pressure monitoring

Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.

Study Groups/Cohorts

Hypertensive patients

No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations.

Intervention: Device: Ambulatory blood pressure monitoring

Publications *

• Omboni S, Posokhov IN, Parati G, Avolio A, Rogoza AN, Kotovskaya YV, Mule G, Muiesan ML, Orlova IA, Grigoricheva EA, Cardona Munoz E, Zelveian PH, Pereira T, Peixoto Maldonado JM. 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. JMIR Res Protoc. 2016 Jun 29;5(2):e137. doi: 10.2196/resprot.5619.
• Omboni S, Posokhov IN, Kotovskaya YV, Protogerou AD, Blacher J. Twenty-Four-Hour Ambulatory Pulse Wave Analysis in Hypertension Management: Current Evidence and Perspectives. Curr Hypertens Rep. 2016 Oct;18(10):72. doi: 10.1007/s11906-016-0681-2.
• Omboni S, Posokhov I, Parati G, Rogoza A, Kotovskaya Y, Arystan A, Avolio A, Barkan V, Bulanova N, Cardona Munoz E, Grigoricheva E, Konradi A, Minyukhina I, Muiesan ML, Mule G, Orlova I, Pereira T, Peixoto Maldonado JM, Statsenko ME, Tilea I, Waisman G; VASOTENS Registry Study Group. 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. J Clin Hypertens (Greenwich). 2019 Aug;21(8):1155-1168. doi: 10.1111/jch.13623. Epub 2019 Jul 11.
• Omboni S, Posokhov I, Parati G, Arystan A, Tan I, Barkan V, Bulanova N, Derevyanchenko M, Grigoricheva E, Minyukhina I, Mule G, Orlova I, Paini A, Peixoto Maldonado JM, Pereira T, Ramos-Becerra CG, Tilea I, Waisman G; VASOTENS Registry Study Group. Variable association of 24-h peripheral and central hemodynamics and stiffness with hypertension-mediated organ damage: the VASOTENS Registry. J Hypertens. 2020 Apr;38(4):701-715. doi: 10.1097/HJH.0000000000002312.
• Omboni S, Campolo L, Panzeri E. Telehealth in chronic disease management and the role of the Internet-of-Medical-Things: the Tholomeus(R) experience. Expert Rev Med Devices. 2020 Jul;17(7):659-670. doi: 10.1080/17434440.2020.1782734. Epub 2020 Jun 30.
• Omboni S, Panzeri E, Campolo L. E-Health in Hypertension Management: an Insight into the Current and Future Role of Blood Pressure Telemonitoring. Curr Hypertens Rep. 2020 Jun 6;22(6):42. doi: 10.1007/s11906-020-01056-y.
• Omboni S. The role of e-health in 24-h monitoring of central haemodynamics and vascular function. 2019; 25(1-2): 11-17.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 14, 2015): 2000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Actual Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects referred to routine diagnostic evaluation for hypertension or established hypertensive subject
• ABPM performed for clinical reasons with a BPLab device
• Valid ambualtory blood pressure recordings (interval between measurements not >30 minutes, at least 70% of expected number of readings, at least 20 valid readings during the day-time and 7 during the night-time)
• Availability of individual measurements for ambulatory blood pressure monitoring
• Availability of basic demographic and clinical information
• Availability of a signed informed consent form

Exclusion Criteria:

• Age <18 years
• Atrial fibrillation, frequent ectopic beats, second or third degree atrioventricular blocks, or other conditions which might make difficult or unreliable the automatic blood pressure measurement with the oscillometric technique
• Upper arm circumference <22 cm
• Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Armenia, Australia, Italy, Kazakhstan, Mexico, Portugal, Romania, Russian Federation, Ukraine

Administrative Information

• NCT Number: NCT02577835
• Other Study ID Numbers: VASOTENS REGISTRY
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Italian Institute of Telemedicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Italian Institute of Telemedicine
• Original Study Sponsor: Same as current
• Collaborators: BPLab

Investigators

• Study Chair: Stefano Omboni, MD; Italian Institute of Telemedicine

• PRS Account: Italian Institute of Telemedicine
• Verification Date: February 2021