International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

NCT02577835 | Completed Results

• 1 other identifier: VASOTENS REGISTRY
• Study Type: observational
• Target: 2,000
• Locations: 9 countries
• Sites: 23

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.

Conditions

Hypertension

Keywords

Hypertension; Arterial Stiffness; Ambulatory blood pressure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 24-hour Systolic Blood Pressure

  2 years

• 24-hour Diastolic Blood Pressure

  2 years

• Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG)

  2 years

• Vascular Damage (Carotid Plaque at Ultrasonography)

  2 years

• Renal Damage (Urine Protein)

  2 years

Study Arms (1)

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

Interventions

Ambulatory blood pressure monitoring DEVICE

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

Hypertensive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Institute of Telemedicine: lead
• BPLab: collaborator

Study Sites (24)

DIM Clinica Privada

Buenos Aires, Argentina

Location

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

Buenos Aires, Argentina

Location

Center of Preventive Cardiology

Yerevan, 00014, Armenia

Location

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

Sydney, Australia

Location

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

Brescia, 25100, Italy

Location

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

Palermo, 90127, Italy

Location

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

Astana, Kazakhstan

Location

University of Guadalajara, Dept. of Physiology

Guadalajara, 44340, Mexico

Location

Clínica da Aveleira, Instituto de Investigação e Formação Cardiovascular

Coimbra, Portugal

Location

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

Coimbra, Portugal

Location

Cardiac Rehabilitation Clinic, Tirgu Mures Emergency Clinical County Hospital

Târgu Mureş, Romania

Location

South Ural State Medical University

Chelyabinsk, Russia

Location

Diagnostics Department, The Hospital within the Russian Railroad Network

Chita, Russia

Location

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

Moscow, Russia

Location

Department of Cardiology, Sechenov First Moscow State Medical University

Moscow, Russia

Location

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

Moscow, Russia

Location

Institute of Personalized Medicine, Sechenov First Moscow State Medical University

Moscow, Russia

Location

Lomonosov Moscow State University Clinic, State University

Moscow, Russia

Location

Volga District Medical Center

Nizhny Novgorod, Russia

Location

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

Petrozavodsk, Russia

Location

Rostov State Medical University

Rostov-at-Don, Russia

Location

North-West Federal Medical Research Centre, Department of Epidemiology

Saint Petersburg, Russia

Location

Volgograd State Medical University

Volgograd, Russia

Location

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

Kyiv, Ukraine

Location

Related Publications (8)

• 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.

  PMID: 27358088 BACKGROUND

• 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.

  PMID: 27659178 BACKGROUND

• 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.

  PMID: 32536214 BACKGROUND

• 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.

  PMID: 32506273 BACKGROUND

• 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.

  PMID: 34518619 BACKGROUND

• 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.

  PMID: 31294910 RESULT

• 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.

  PMID: 31834122 RESULT

• 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.

  PMID: 38747378 RESULT

Related Links

• The official website of the study

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Results Point of Contact

• Title: Stefano Omboni
• Organization: Italian Institute of Telemedicine

stefano.omboni@iitelemed.org

00390331984176

Study Officials

• Stefano Omboni, MD

  Italian Institute of Telemedicine

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 16, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2022
• Last Updated: December 16, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-10

Locations

AR (2); ME (1); AU (1); IT (2); KA (1); UA (1); PT (2); RO (1); RU (12)