N/A
N=1,342
International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02577835 ↗Enrolled (actual)
1,342
Serious AEs
13.5%
Results posted
Mar 2024
Primary outcome: Primary: 24-hour Pulse Wave Velocity (PWV) — 10.6 m/s
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ambulatory blood pressure monitoring (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Italian Institute of Telemedicine
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 24-hour Pulse Wave Velocity (PWV) |
10.6 | — |
| PRIMARY 24-hour Augmentation Index (AI) |
18.0 | — |
| PRIMARY 24-hour Central Blood Pressure |
117.2 | — |
| SECONDARY 24-hour Systolic Blood Pressure |
128.1 | — |
| SECONDARY 24-hour Diastolic Blood Pressure |
79.4 | — |
| SECONDARY Cardiac Damage (Left Ventricular Hypertrophy at Echocardiogram or ECG) |
109.6 | — |
| SECONDARY Vascular Damage (Carotid Plaque at Ultrasonography) |
1.2 | — |
| SECONDARY Renal Damage (Urine Protein) |
105.4 | — |
| SECONDARY Combination of Non-fatal and Fatal CV and Renal Events or All-cause Death |
104 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02577835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.