International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Hypertension Clinical Trial

— VASOTENS  

Official title:

International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577835
• Other study ID #: VASOTENS REGISTRY
• Status: Completed
• Start date: November 2015
• Est. completion date: April 2022

Study information

• Verified date: August 2023
• Source: Italian Institute of Telemedicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: April 2022
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Italian Institute of Telemedicine	BPLab

Countries where clinical trial is conducted

Argentina,  Armenia,  Australia,  Italy,  Kazakhstan,  Mexico,  Portugal,  Romania,  Russian Federation,  Ukraine, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Variab — View 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; V — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   The official website of the study