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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT02577835 |
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Date of registration:
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13/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
VASOTENS |
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Scientific title:
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International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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2000 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02577835 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Argentina
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Armenia
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Australia
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Italy
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Kazakhstan
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Mexico
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Portugal
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Romania
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Russian Federation
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Ukraine
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Contacts
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Name:
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Stefano Omboni, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Italian Institute of Telemedicine |
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Name:
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Stefano Omboni, MD |
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Address:
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Telephone:
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+390331984176 |
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Email:
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stefano.omboni@iitelemed.org |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Device: Ambulatory blood pressure monitoring
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Primary Outcome(s)
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24-hour Central Blood Pressure
[Time Frame: 2 years]
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24-hour Augmentation Index (AI)
[Time Frame: 2 years]
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24-hour Pulse Wave Velocity (PWV)
[Time Frame: 2 years]
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Secondary Outcome(s)
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24-hour Diastolic Blood Pressure
[Time Frame: 2 years]
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Renal damage (urine protein)
[Time Frame: 2 years]
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24-hour Systolic and Diastolic Blood Pressure standard deviation
[Time Frame: 2 years]
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Cardiac Damage (left ventricular hypertrophy at echocardiogram or ECG)
[Time Frame: 2 years]
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24-hour Systolic Blood Pressure
[Time Frame: 2 years]
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Cardiovascular fatal and non fatal events
[Time Frame: 2 years]
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24-hour Systolic and Diastolic Blood Pressure average real variability
[Time Frame: 2 years]
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24-hour Systolic and Diastolic Blood Pressure weighted standard deviation
[Time Frame: 2 years]
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Vascular Damage (carotid plaque at ultrasonography)
[Time Frame: 2 years]
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Secondary ID(s)
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VASOTENS REGISTRY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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