OBPM_FORESEE2024

  • Research type

    Research Study

  • Full title

    OBPM_FORESEE2024: Evaluation of the clinical benefit of the Aktiia Blood Pressure monitoring for early awareness of hypertension and prediction of cardiovascular risk in a multi-ethnic European population: an observational cohorts’ study

  • IRAS ID

    353439

  • Contact name

    Manish Saxena

  • Contact email

    m.saxena@qmul.ac.uk

  • Sponsor organisation

    AKTIIA SA

  • Clinicaltrials.gov Identifier

    NCT06670677

  • Duration of Study in the UK

    10 years, 0 months, 1 days

  • Research summary

    This is a fully remote research project utilizing two CE-marked Aktiia devices: the Aktiia G1, which provides continuous blood pressure (BP) measurement at the wrist via a bracelet, and the Aktiia G2C, designed for spot-check BP measurement at the fingertip using a compatible smartphone camera.

    The goal of this study is to correlate, for the first time, continuous wrist-based and punctual fingertip blood pressure monitoring with the evolution of environmental and health factors. This will support improved hypertension management and contribute to the development of initial models for cardiovascular risk prediction.

    This international study is being conducted in Switzerland, Germany, and the United Kingdom. It includes three study cohorts with a total of 15,000 participants (approximately 5,000 per country), running in parallel:

    ARM 1 and ARM 2: These groups consist of existing Aktiia G1 users (individuals who already own an Aktiia G1 device).
    ARM 3: This group includes participants who do not own an Aktiia G1 device.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    25/NW/0026

  • Date of REC Opinion

    21 Jan 2025

  • REC opinion

    Favourable Opinion