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International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring

NCT02577835 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-12-16

Study results available
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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.

Conditions

Interventions

DEVICE

Ambulatory blood pressure monitoring

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

Sponsors & Collaborators

  • BPLab

    collaborator OTHER

  • Italian Institute of Telemedicine

    lead OTHER

Principal Investigators

  • Stefano Omboni, MD · Italian Institute of Telemedicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-12-31
Completion
2022-04-30

Countries

  • Argentina
  • Armenia
  • Australia
  • Italy
  • Kazakhstan
  • Mexico
  • Portugal
  • Romania
  • Russia
  • Ukraine

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577835 on ClinicalTrials.gov