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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02577835




Registration number
NCT02577835
Ethics application status
Date submitted
13/10/2015
Date registered
16/10/2015
Date last updated
15/02/2021

Titles & IDs
Public title
International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
Scientific title
International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
Secondary ID [1] 0 0
VASOTENS REGISTRY
Universal Trial Number (UTN)
Trial acronym
VASOTENS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Ambulatory blood pressure monitoring

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.


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
24-hour Pulse Wave Velocity (PWV) - 24-hour average value for arterial stifness (m/s)
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
24-hour Augmentation Index (AI) - 24-hour average value for waves reflection (percent)
Timepoint [2] 0 0
2 years
Primary outcome [3] 0 0
24-hour Central Blood Pressure - 24-hour average central aortic pressure (mmHg)
Timepoint [3] 0 0
2 years
Secondary outcome [1] 0 0
24-hour Systolic Blood Pressure - Average 24-hour brachial systolic blood pressure (mmHg)
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
24-hour Diastolic Blood Pressure - Average 24-hour brachial diastolic blood pressure (mmHg)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
24-hour Systolic and Diastolic Blood Pressure standard deviation - A measure of blood pressure variability (mmHg)
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
24-hour Systolic and Diastolic Blood Pressure weighted standard deviation - A measure of blood pressure variability (mmHg)
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
24-hour Systolic and Diastolic Blood Pressure average real variability - A measure of blood pressure variability (mmHg)
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Cardiac Damage (left ventricular hypertrophy at echocardiogram or ECG) - Left ventricular hypertrophy indexed by body surface area (g/m^2)
Timepoint [6] 0 0
2 years
Secondary outcome [7] 0 0
Vascular Damage (carotid plaque at ultrasonography) - Intima media tickness (mmm)
Timepoint [7] 0 0
2 years
Secondary outcome [8] 0 0
Renal damage (urine protein) - Urine proteine (mg/24h)
Timepoint [8] 0 0
2 years
Secondary outcome [9] 0 0
Cardiovascular fatal and non fatal events - Cardiovascular outcomes
Timepoint [9] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Armenia
State/province [2] 0 0
Erevan
Country [3] 0 0
Italy
State/province [3] 0 0
Brescia
Country [4] 0 0
Italy
State/province [4] 0 0
Palermo
Country [5] 0 0
Kazakhstan
State/province [5] 0 0
Astana
Country [6] 0 0
Mexico
State/province [6] 0 0
Guadalajara
Country [7] 0 0
Portugal
State/province [7] 0 0
Coimbra
Country [8] 0 0
Romania
State/province [8] 0 0
Târgu-Mures
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Chelyabinsk
Country [10] 0 0
Russian Federation
State/province [10] 0 0
Chita
Country [11] 0 0
Russian Federation
State/province [11] 0 0
Moscow
Country [12] 0 0
Russian Federation
State/province [12] 0 0
Nizhniy Novgorod
Country [13] 0 0
Russian Federation
State/province [13] 0 0
Petrozavodsk
Country [14] 0 0
Russian Federation
State/province [14] 0 0
Rostov-at-Don
Country [15] 0 0
Russian Federation
State/province [15] 0 0
St. Petersburg
Country [16] 0 0
Russian Federation
State/province [16] 0 0
Volgograd
Country [17] 0 0
Ukraine
State/province [17] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Other
Name
Italian Institute of Telemedicine
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
BPLab
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02577835
Trial related presentations / publications
Omboni S, Posokhov IN, Parati G, Avolio A, Rogoza AN, Kotovskaya YV, Mulè G, Muiesan ML, Orlova IA, Grigoricheva EA, Cardona Muñoz 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.
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. Review.
Public notes

Contacts
Principal investigator
Name 0 0
Stefano Omboni, MD
Address 0 0
Italian Institute of Telemedicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stefano Omboni, MD
Address 0 0
Country 0 0
Phone 0 0
+390331984176
Fax 0 0
Email 0 0
stefano.omboni@iitelemed.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02577835