ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02577835
Recruitment Status : Recruiting
First Posted : October 16, 2015
Last Update Posted : December 26, 2016
Sponsor:
Collaborator:
BPLab
Information provided by (Responsible Party):
Italian Institute of Telemedicine

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.

Condition or disease Intervention/treatment
Hypertension 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 [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
Study Start Date : November 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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.




Primary Outcome Measures :
  1. 24-hour Pulse Wave Velocity (PWV) [ Time Frame: 2 years ]
  2. 24-hour Augmentation Index (AI) [ Time Frame: 2 years ]
  3. 24-hour Central Blood Pressure [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 24-hour Systolic Blood Pressure [ Time Frame: 2 years ]
  2. 24-hour Diastolic Blood Pressure [ Time Frame: 2 years ]
  3. 24-hour Systolic and Diastolic Blood Pressure standard deviation [ Time Frame: 2 years ]
    A measure of blood pressure variability

  4. 24-hour Systolic and Diastolic Blood Pressure weighted standard deviation [ Time Frame: 2 years ]
    A measure of blood pressure variability

  5. 24-hour Systolic and Diastolic Blood Pressure average real variability [ Time Frame: 2 years ]
    A measure of blood pressure variability

  6. Cardiac Damage (left ventricular hypertrophy at echocardiogram or ECG) [ Time Frame: 2 years ]
  7. Vascular Damage (carotid plaque at ultrasonography) [ Time Frame: 2 years ]
  8. Renal damage (urine protein) [ Time Frame: 2 years ]
  9. Cardiovascular fatal and non fatal events [ Time Frame: 2 years ]
    Cardiovascular outcomes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577835


Contacts
Contact: Stefano Omboni, MD +390331984176 stefano.omboni@iitelemed.org

Locations
Argentina
DIM Clinica Privada Recruiting
Buenos Aires, Argentina
Contact: Pedro Forcada, MD         
Armenia
Center of Preventive Cardiology Recruiting
Erevan, Armenia, 00014
Contact: Parounak Zelveian, MD         
Australia
Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Macquarie University Recruiting
Sydney, Australia
Contact: Alberto Avolio         
Sub-Investigator: Mark Butlin, MD         
Sub-Investigator: Edward Barin, MD         
Italy
Dipartimento di Scienze Mediche e Chirurgiche, Università di Brescia, Medicina 2, Spedali Civili Recruiting
Brescia, Italy, 25100
Contact: Maria Lorenza Muiesan, MD         
Sub-Investigator: Anna Paini, MD         
Sub-Investigator: Damiano Rizzoni, MD         
Unità Operativa di Nefrologia ed Ipertensione, Centro di Riferimento Regionale per l'Ipertensione Arteriosa, Policlinico Paolo Giaccone Recruiting
Palermo, Italy, 90127
Contact: Giuseppe Mulè, MD         
Mexico
University of Guadalajara, Dept. of Physiology Recruiting
Guadalajara, Mexico, 44340
Contact: Ernesto Cardona Muñoz, MD         
Sub-Investigator: Carlos Ramos, MD         
Sub-Investigator: Adrian Alanis, MD         
Portugal
Clínica da Aveleira, Instituto de Investigação e Formação Cardiovascular Recruiting
Coimbra, Portugal
Contact: João Manuel Peixoto Maldonado, MD         
Escola Superior de Tecnologia da Saúde de Coimbra , Instituto Politécnico de Coimbra Recruiting
Coimbra, Portugal
Contact: Telmo Pereira, MD         
Romania
Cardiac Rehabilitation Clinic, Tirgu Mures Emergency Clinical County Hospital Recruiting
Tirgu Mures, Romania
Contact: Ioan Tilea, MD         
Sub-Investigator: Andreaa Varga, MD         
Russian Federation
South Ural State Medical University Recruiting
Chelyabinsk, Russian Federation
Contact: Elena Grigoricheva, MD         
Sub-Investigator: Vitaly V Evdokimov, MD         
Sub-Investigator: Anastasiya Y Kuznetsova, MD         
Diagnostics Department, The Hospital within the Russian Railroad Network Recruiting
Chita, Russian Federation
Contact: Vitaliy Barkan, MD         
Sub-Investigator: Marina Gubanova, MD         
Sub-Investigator: Viktoria Lazareva         
Department of Cardiology and Personalized Medicine, Faculty of Doctors' Advanced Training, Peoples' Friendship University of Russia Recruiting
Moscow, Russian Federation
Contact: Yulia Kotovskaya, MD         
Department of Propaedeutics of Internal Diseases, Medical Faculty, Peoples' Friendship University of Russia Recruiting
Moscow, Russian Federation
Contact: Zhanna Kobalava, MD         
Lomonosov Moscow State University Clinic, State University Recruiting
Moscow, Russian Federation
Contact: Iana Orlova, MD         
Sub-Investigator: Natalya Kurlykina, MD         
Volga District Medical Center Recruiting
Nizhniy Novgorod, Russian Federation
Contact: Irina Minyukhina, MD         
Sub-Investigator: Irina Borisova         
Sub-Investigator: Tatiana Svetozarsky         
Petrosavodsk Research Center and Department of Faculty Therapy, Infectious Diseases and Epidemiology, Petrozavodsk State University Recruiting
Petrozavodsk, Russian Federation
Contact: Viktoria Korneva, MD         
Sub-Investigator: Tatyana Kuznetsova, MD         
Rostov State Medical University Recruiting
Rostov-at-Don, Russian Federation
Contact: Elena Zheleznyak, MD         
Sub-Investigator: El Zhelezniak, MD         
North-West Federal Medical Research Centre, Department of Epidemiology Recruiting
St. Petersburg, Russian Federation
Contact: Alexandra Konradi, MD         
Sub-Investigator: Oxana Rotar, MD         
Sub-Investigator: Alexander Orlov, MD         
Ukraine
National Scientific Center "M.D. Strazhesko Institute of Cardiology" Recruiting
Kyiv, Ukraine
Contact: Yuriy M Sirenko, MD         
Sub-Investigator: Oksana Recovets         
Sponsors and Collaborators
Italian Institute of Telemedicine
BPLab
Investigators
Study Chair: Stefano Omboni, MD Italian Institute of Telemedicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Italian Institute of Telemedicine
ClinicalTrials.gov Identifier: NCT02577835     History of Changes
Other Study ID Numbers: VASOTENS REGISTRY
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Italian Institute of Telemedicine:
Hypertension
Arterial Stiffness
Ambulatory blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases