CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,000 enrolled
Drug / intervention
Ambulatory blood pressure monitoringdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02577835
NCT02577835N/ACompleted

International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

Italian Institute of Telemedicine·observational·Posted Oct 16, 2015·Updated Dec 16, 2024

In Brief

An observational study evaluating Ambulatory blood pressure monitoring for Hypertension. Completed, enrolled 2,000 participants across 24 sites in 10 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesArgentina, Armenia, Australia, Italy, Kazakhstan, Mexico, Portugal, Romania, Russia, Ukraine
CollaboratorsBPLab

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 16, 2015
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2018
Study CompletionApr 1, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.7 years ago

Interventions

Ambulatory blood pressure monitoringdevice

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