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NCT Number: NCT06831890

Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data

The goal of the clinical trial is to assess whether the data collected from wearable devices can reduce the uncertainty in predicting the cardiovascular disease (CVD) risk in women aged 40-69 years in a situation where information about the blood pressure and blood lipids are unavailable.

Participants will:

* Complete a screening and baseline assessment, including blood sample collection and vital parameter measurement. * Wear a wearable device for one week. * Fill in a work and sleep journal. * Complete a last visit assessment.

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Key information

Conditions

Cardiovascular Diseases Menopause

Age range

40 year–69 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Petra Stute, Prof.

CONTACT

[email protected]

+41 31 632 1010

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Fluency in German (written and oral).
Ownership of a smartphone.
Signing the informed consent form.

Exclusion criteria

Diagnosis of cardiovascular disease.
Diagnosis of diabetes mellitus.
Diagnosis of chronic kidney disease.
Diagnosis of familial hypercholesterolemia.
Incapable of providing informed consent.
Current employment at the Section Gynecological Endocrinology and Reproductive Medicine of the Department for Obstetrics and Gynecology at the Inselspital Bern or any other professional relation to one of the study project leaders / investigators.
Concurrent participation in a clinical intervention study.
Inability to comply with the study procedures for any reason, including language comprehension, psychiatric illness, general inability to get to the study site.
Participant's smartphone not compatible with Fitrockr.
Technical inability of participant's smartphone to connect to the smartwatch.

Treatment and study plan

Primary outcomes

Reduction in CVD Risk Prediction Uncertainty Using Wearable Data

Time frame: After 7-day wearable data collection period.

Assessment of the reduction in prediction uncertainty of cardiovascular disease (CVD) risk in women aged 40-69 years when wearable-derived data (e.g., heart rate, daily step count) is used to replace missing physician-recorded inputs (e.g., blood pressure and lipid levels). The reduction will be quantified using the Continuous Ranked Probability Score (CRPS), whereby smaller CRPS values indicate improved performance. An improvement is considered substantial if introducing wearable data reduces CRPS by at least 5%.

Secondary outcomes

Identification of wearable data that improve cardiovascular disease risk prediction without clinical key inputs

Time frame: After 7-day wearable data collection period.

Identifying specific data from wearable devices that most effectively reduce uncertainty in predicting CVD risk in the absence of information on blood pressure, blood lipids, and the presence or absence of metabolic syndrome. To achieve this, statistical and machine learning methods capable of handling irregularly samples time series of bio-signals recorded by the wearable devices will be applied.

Study contacts

Contact information is provided by the study sponsor or research team.

Petra Stute, Prof.

CONTACT

[email protected]

+41 31 632 1010

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data - A Cross-sectional Study in Apparently Healthy Women Aged 40 to 69 Years (Frauenherzen)

Acronym: Frauenherzen

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Feb 18, 2025
Registry last updated: Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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