Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk

ConditionsHypertension Cardiovascular Risk Blood Pressure Check (Hypertension Screening)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age21-85

SponsorAktiia SA

About this trial

Because Aktiia S.A. has been the first-ever company to put in the market an Optical Blood Pressure Monitoring device, there is a need for Aktiia S.A. to correlate for the first time continual Blood Pressure monitoring and the evolution of environmental and health factors to improve hypertension management.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult subjects aged 21 to 85 years old

Subjects living in Switzerland, Germany or in the UK

Subjects agreeing to follow the study procedures.

Disqualifiers

Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including resting tachycardia (heart rate at rest > 120bpm) and atrial fibrillation;

Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL / min / 1.73 m2), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula;

Subjects suffering from polyneuropathy;

on pregnant women;

Trial population

Any subjects that respect the study inclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Lifestyle survey completion
Other intervention
For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
Unlimited on-demand blood pressure measurements with G2C
Other intervention
For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated
Continual blood pressure measurements with G1
Other intervention
For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project.

Treatment groups

15,000 Participants

are divided into 3 treatment groups

Group A: ARM 1 G1 Aktiia users Android3 interventions

Group B: ARM 2 G1 AKTIIA users iOS3 interventions

Group C: ARM 3 non-Aktiia-G1-users Android & iOS2 interventions

Trial outcomes

Primary outcomes

Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors

Strength and direction of the correlation coefficient between continuous blood pressure readings and various survey-derived factors such as sociodemographic variables, lifestyle habits, and health metrics.

Time frame

10 years

Secondary outcomes

Global scale projections of the benefit of the early awareness of hypertension with the spot-check Aktiia G2C device at the fingertip

Proportion of subjects with early hypertension awareness enabled by the fingertip spot-check feature of the Aktiia G2C device.

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aktiia SA

Lead sponsor

Source ClinicalTrials.gov

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