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N/A N=1,342

International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Hypertension

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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