Clinical trial NCT02577835: International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
Official title: International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Arterial Stiffness
Ambulatory blood pressure
Lead sponsor: Italian Institute of Telemedicine
Sponsor class: OTHER
Collaborators: name: BPLab
First posted: 2015-10-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Suspected hypertensive patients referred to routine diagnostic evaluation for their condition (hypertension) or established hypertensive subjects

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.

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

Primary outcomes:
measure: 24-hour Pulse Wave Velocity (PWV)
timeFrame: 2 years
measure: 24-hour Augmentation Index (AI)
timeFrame: 2 years
measure: 24-hour Central Blood Pressure
timeFrame: 2 years
Secondary outcomes:
measure: 24-hour Systolic Blood Pressure
timeFrame: 2 years
measure: 24-hour Diastolic Blood Pressure
timeFrame: 2 years
measure: Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG)
timeFrame: 2 years
measure: Vascular Damage (Carotid Plaque at Ultrasonography)
timeFrame: 2 years
measure: Renal Damage (Urine Protein)
timeFrame: 2 years
measure: Combination of Non-fatal and Fatal CV and Renal Events or All-cause Death
timeFrame: 4 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: DIM Clinica Privada
city: Buenos Aires
country: Argentina
facility: Servicio de Clínica Médica y Sección Hipertensión Arterial, Hospital Italiano de Buenos Aires
city: Erevan
country: Armenia
facility: Center of Preventive Cardiology
city: Sydney
country: Australia
facility: Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Macquarie University
city: Brescia
country: Italy
facility: Dipartimento di Scienze Mediche e Chirurgiche, Università di Brescia, Medicina 2, Spedali Civili
city: Palermo
country: Italy
facility: Unità Operativa di Nefrologia ed Ipertensione, Centro di Riferimento Regionale per l'Ipertensione Arteriosa, Policlinico Paolo Giaccone
city: Astana
country: Kazakhstan
facility: Department of Functional Diagnostics, Medical Centre Hospital of President's Affairs Administration of The Republic of Kazakhstan
city: Guadalajara
country: Mexico
facility: University of Guadalajara, Dept. of Physiology
city: Coimbra
country: Portugal
facility: Clínica da Aveleira, Instituto de Investigação e Formação Cardiovascular
city: Coimbra
country: Portugal
facility: Escola Superior de Tecnologia da Saúde de Coimbra , Instituto Politécnico de Coimbra
city: Târgu-Mureş
country: Romania
facility: Cardiac Rehabilitation Clinic, Tirgu Mures Emergency Clinical County Hospital
city: Chelyabinsk
country: Russian Federation
facility: South Ural State Medical University
city: Chita
country: Russian Federation
facility: Diagnostics Department, The Hospital within the Russian Railroad Network
city: Moscow
country: Russian Federation
facility: Department of Cardiology and Personalized Medicine, Faculty of Doctors' Advanced Training, Peoples' Friendship University of Russia
city: Moscow
country: Russian Federation
facility: Department of Cardiology, Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: Department of Propaedeutics of Internal Diseases, Medical Faculty, Peoples' Friendship University of Russia
city: Moscow
country: Russian Federation
facility: Institute of Personalized Medicine, Sechenov First Moscow State Medical University
city: Moscow
country: Russian Federation
facility: Lomonosov Moscow State University Clinic, State University
city: Nizhniy Novgorod
country: Russian Federation
facility: Volga District Medical Center
city: Petrozavodsk
country: Russian Federation
facility: Petrosavodsk Research Center and Department of Faculty Therapy, Infectious Diseases and Epidemiology, Petrozavodsk State University
city: Rostov-at-Don
country: Russian Federation
facility: Rostov State Medical University
city: St. Petersburg
country: Russian Federation
facility: North-West Federal Medical Research Centre, Department of Epidemiology
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University
city: Kyiv
country: Ukraine
facility: National Scientific Center "M.D. Strazhesko Institute of Cardiology"
Study officials:
affiliation: Italian Institute of Telemedicine
name: Stefano Omboni, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Omboni S, Alfie J, Arystan A, Avolio A, Barin E, Bokusheva J, Bulanova N, Butlin M, Cuffaro P, Derevyanchenko M, Grigoricheva E, Gurevich A, Konradi A, Muiesan ML, Paini A, Pereira T, Statsenko ME, Tan I; VASOTENS Registry Study Group. Association of 24-h central hemodynamics and stiffness with cardiovascular events and all-cause mortality. The VASOTENS Registry. J Hypertens. 2024 Sep 1;42(9):1590-1597. doi: 10.1097/HJH.0000000000003763. Epub 2024 May 15.