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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Ambulatory blood pressure monitoring

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
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • DIM Clínica Privada
  • Buenos Aires, Argentina
    • Servicio de Clínica Médica y Sección Hipertensión Arterial, Hospital Italiano de Buenos Aires
• Armenia
  • Erevan, Armenia, 00014
    • Center of Preventive Cardiology
• Australia
  • Sydney, Australia
    • Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Macquarie University
• Italy
  • Brescia, Italy, 25100
    • Dipartimento di Scienze Mediche e Chirurgiche, Università di Brescia, Medicina 2, Spedali Civili
  • Palermo, Italy, 90127
    • Unità Operativa di Nefrologia ed Ipertensione, Centro di Riferimento Regionale per l'Ipertensione Arteriosa, Policlinico Paolo Giaccone
• Kazakhstan
  • Astana, Kazakhstan
    • Department of Functional Diagnostics, Medical Centre Hospital of President's Affairs Administration of The Republic of Kazakhstan
• Mexico
  • Guadalajara, Mexico, 44340
    • University of Guadalajara, Dept. of Physiology
• Portugal
  • Coimbra, Portugal
    • Clínica da Aveleira, Instituto de Investigação e Formação Cardiovascular
  • Coimbra, Portugal
    • Escola Superior de Tecnologia da Saúde de Coimbra , Instituto Politécnico de Coimbra
• Romania
  • Târgu-Mureş, Romania
    • Cardiac Rehabilitation Clinic, Tirgu Mures Emergency Clinical County Hospital
• Russian Federation
  • Chelyabinsk, Russian Federation
    • South Ural State Medical University
  • Chita, Russian Federation
    • Diagnostics Department, The Hospital within the Russian Railroad Network
  • Moscow, Russian Federation
    • Department of Cardiology and Personalized Medicine, Faculty of Doctors' Advanced Training, Peoples' Friendship University of Russia
  • Moscow, Russian Federation
    • Department of Cardiology, Sechenov First Moscow State Medical University
  • Moscow, Russian Federation
    • Department of Propaedeutics of Internal Diseases, Medical Faculty, Peoples' Friendship University of Russia
  • Moscow, Russian Federation
    • Institute of Personalized Medicine, Sechenov First Moscow State Medical University
  • Moscow, Russian Federation
    • Lomonosov Moscow State University Clinic, State University
  • Nizhniy Novgorod, Russian Federation
    • Volga District Medical Center
  • Petrozavodsk, Russian Federation
    • Petrosavodsk Research Center and Department of Faculty Therapy, Infectious Diseases and Epidemiology, Petrozavodsk State University
  • Rostov-at-Don, Russian Federation
    • Rostov State Medical University
  • St. Petersburg, Russian Federation
    • North-West Federal Medical Research Centre, Department of Epidemiology
  • Volgograd, Russian Federation
    • Volgograd State Medical University
• Ukraine
  • Kyiv, Ukraine
    • National Scientific Center "M.D. Strazhesko Institute of Cardiology"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Suspected hypertensive patients referred to routine diagnostic evaluation for their condition (hypertension) or established hypertensive subjects

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour Pulse Wave Velocity (PWV)	24-hour average value for arterial stiffness was assessed through estimation of the time traveled by the pulse wave from the central arterial tree (aorta) to the peripheral arteries (brachial artery) and measured in meters per sec. The faster the wave travels through the arterial tree, the stiffer the artery is.	2 years
24-hour Augmentation Index (AI)	24-hour average value for waves reflection expressed as a percentage. The augmentation index is a measure of wave reflection and arterial stiffness and is commonly measured as the ratio of the central pulse pressure and the reflected pulse pressure which augments the central blood pressure. When arteries are stiff, a reflected wave is formed where arteries split. This reflected wave moves back at the heart and increases the pressure at which the heart has to pump. The higher the index the stiffer the artery is.	2 years
24-hour Central Blood Pressure	24-hour average central aortic pressure expressed in mmHg, as the estimated blood pressure at the level of the thoracic aorta	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour Systolic Blood Pressure	Average 24-hour brachial systolic blood pressure (mmHg), namely the systolic blood pressure measured at the level of the brachial artery (upper arm).	2 years
24-hour Diastolic Blood Pressure	Average 24-hour brachial diastolic blood pressure (mmHg), namely the diastolic blood pressure measured at the level of the brachial artery (upper arm).	2 years
Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG)	Left ventricular mass indexed by body surface area (g/m^2) is used to identify left ventricular hypertrophy in case it is increased above a certain threshold (see protocol).	2 years
Vascular Damage (Carotid Plaque at Ultrasonography)	Intima media tickness (mm) measured by carotid ultrasonography is used to identify wall thickening or atherosclerotic plaque, when it is above a certain threshold (see protocol).	2 years
Renal Damage (Urine Protein)	Urine proteine (mg/24h). The increase above a certain threshold of urine protein is a sign of renal damage (see protocol).	2 years

Collaborators and Investigators

• Sponsor: Italian Institute of Telemedicine
• Collaborators: BPLab
• Investigators: Study Chair: Stefano Omboni, MD, Italian Institute of Telemedicine

Publications and helpful links

General 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, Arystan A, Benczur B. Ambulatory monitoring of central arterial pressure, wave reflections, and arterial stiffness in patients at cardiovascular risk. J Hum Hypertens. 2022 Apr;36(4):352-363. doi: 10.1038/s41371-021-00606-4. Epub 2021 Sep 13.

Helpful Links

• The official website of the study

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimated): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Arterial Stiffness; Ambulatory blood pressure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: VASOTENS REGISTRY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED