International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Hypertension

Keywords

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Hypertension Arterial Stiffness Ambulatory blood pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ambulatory blood pressure monitoring

Intervention Type DEVICE

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

Interventions

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Ambulatory blood pressure monitoring

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefano Omboni, MD

Role: STUDY_CHAIR

Italian Institute of Telemedicine

Kyiv, , Ukraine

Site Status

Countries

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Argentina Armenia Australia Italy Kazakhstan Mexico Portugal Romania Russia Ukraine

Reference Type RESULT

PMID: 38747378 (View on PubMed)

Provided Documents

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Other Identifiers

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VASOTENS REGISTRY

Identifier Type: -

Identifier Source: org_study_id

International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Hypertensive patients

Ambulatory blood pressure monitoring

Interventions

Ambulatory blood pressure monitoring

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

BPLab

Italian Institute of Telemedicine

Responsible Party

Principal Investigators

Stefano Omboni, MD

Locations

DIM Clinica Privada

Servicio de Clínica Médica y Sección Hipertensión Arterial, Hospital Italiano de Buenos Aires

Center of Preventive Cardiology

Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Macquarie University

Dipartimento di Scienze Mediche e Chirurgiche, Università di Brescia, Medicina 2, Spedali Civili

Unità Operativa di Nefrologia ed Ipertensione, Centro di Riferimento Regionale per l'Ipertensione Arteriosa, Policlinico Paolo Giaccone

Department of Functional Diagnostics, Medical Centre Hospital of President's Affairs Administration of The Republic of Kazakhstan

University of Guadalajara, Dept. of Physiology

Clínica da Aveleira, Instituto de Investigação e Formação Cardiovascular

Escola Superior de Tecnologia da Saúde de Coimbra , Instituto Politécnico de Coimbra

Cardiac Rehabilitation Clinic, Tirgu Mures Emergency Clinical County Hospital

South Ural State Medical University

Diagnostics Department, The Hospital within the Russian Railroad Network

Department of Cardiology and Personalized Medicine, Faculty of Doctors' Advanced Training, Peoples' Friendship University of Russia

Department of Cardiology, Sechenov First Moscow State Medical University

Department of Propaedeutics of Internal Diseases, Medical Faculty, Peoples' Friendship University of Russia

Institute of Personalized Medicine, Sechenov First Moscow State Medical University

Lomonosov Moscow State University Clinic, State University

Volga District Medical Center

Petrosavodsk Research Center and Department of Faculty Therapy, Infectious Diseases and Epidemiology, Petrozavodsk State University

Rostov State Medical University

North-West Federal Medical Research Centre, Department of Epidemiology

Volgograd State Medical University

National Scientific Center "M.D. Strazhesko Institute of Cardiology"

Countries

References

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, 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.

Provided Documents

Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Document Type: Informed Consent Form

Related Links

Other Identifiers

VASOTENS REGISTRY