Status:

NOT_YET_RECRUITING

Smartphone Blood Pressure Measurement to Screen for Hypertension

Lead Sponsor:

Centre Hospitalier Universitaire Vaudois

Conditions:

Blood Pressure

Blood Pressure Disorders

Eligibility:

All Genders

18-80 years

Brief Summary

The goal of this observational study is to assess the feasibility of classifying people whose blood pressures are within hypertensive range using a machine-learning approach based on features derived ...

Detailed Description

This is a single-center observational pilot study. Data will be collected prospectively on 100 participants (maximum of 120) with, ideally, 50 presumed healthy volunteers and 50 participants with a su...

Eligibility Criteria

Inclusion

  • Informed consent as documented by signature
  • Men or women older than 18 years old
  • Good understanding of written and oral speaking used at the center where the study will be carried out

Exclusion

  • Patients that cannot sign informed consent
  • Patients in emergency situation, are not legally competent, cannot understand the situation or are vulnerable
  • Unable to participate due to pain or stress \[12\]
  • Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
  • Patients older than 80 years old \[4\] \[13\]
  • Known pregnancy
  • Known unstable cardiac condition (myocardial infarction \< 1 week, decompensated heart failure, pulmonary embolism)
  • End-stage renal disease (GFR \< 15/min/1.73m2 and/or dialysis) \[4\] \[14\] \[15\] \[16\]
  • Diabetes mellitus \[15\] \[8\]
  • Known (or assessed by recording heart rate and using pulse palpation, as recommended in ESC/ESH guidelines \[1\]) cardiac arrhythmia (atrial fibrillation, numerous extrasystoles and important bradycardia/bradyarrhythmia, bigeminy, trigeminy, isolated VPB) \[4\] \[1\] \[7\] \[15\] \[17\]
  • SBP or DBP difference between two arms \>10 mmHg \[8\] \[18\]
  • Patient with finger lesions that would alter the correct capture of signals by the mobile phone.
  • Known mobile phone contact dermatitis (caused by metal allergens, notably nickel and chromium
  • Incapacity of properly using the smartphone (i.e. incapacity of obtaining a recording with sufficient signal quality after the dedicated training)

Key Trial Info

Start Date :

September 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2025

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06577688

Start Date

September 1 2024

End Date

September 30 2025

Last Update

August 29 2024

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