Mode
Text Size
Log in / Sign up
N/A Completed N=1,342

International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Source: ClinicalTrials.gov NCT02577835 ↗
Enrolled (actual)
1,342
Serious AEs
13.5%
Results posted
Mar 2024
Primary outcomePrimary: 24-hour Pulse Wave Velocity (PWV) — 10.6 m/s

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.

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 —

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. Informational only — not medical advice.

Back to search