Cardiovascular DiseasesFrauenherzenNCT06831890
Surrogating Physician-recorded SCORE2 Risk Calculator Inputs by Using Auxiliary Data
An observational study of Cardiovascular Diseases and Menopause, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Menopause
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 24 Aug 2023to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include women aged 40 to 69 years who meet the inclusion and exclusion criteria.
Who may be able to join
- Fluency in German (written and oral).
- Ownership of a smartphone.
- Signing the informed consent form.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
Bern, 3010
Petra Stute, Prof., +41 31 632 1010, petra.stute@insel.ch
About this study
Official 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)
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.
- Conditions
- Cardiovascular Diseases, Menopause
- Keywords
- Menopause, Cardiovascular disease risk, Wearables, SCORE2, Health monitoring
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Apparently healthy women aged 40 to 69 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in CVD Risk Prediction Uncertainty Using Wearable Data
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%.
Measured: After 7-day wearable data collection period.
Secondary outcomes (1)
Identification of wearable data that improve cardiovascular disease risk prediction without clinical key inputs
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.
Measured: After 7-day wearable data collection period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start24 Aug 2023
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petra Stute, Prof., Principal investigator, University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831890
- Sponsor's protocol ID
- 2022-02080
- Acronym
- Frauenherzen
- Status last verified
- Feb 2025
- First submitted
- 20 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06831890
- Acronym / sponsor ID
- Frauenherzen / 2022-02080
- Conditions
- Cardiovascular Diseases, Menopause
- Keywords
- Menopause, Cardiovascular disease risk, Wearables, SCORE2, Health monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apparently healthy women aged 40 to 69 years | – | – |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include women aged 40 to 69 years who meet the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- Fluency in German (written and oral).
- Ownership of a smartphone.
- Signing the informed consent form.
Key exclusion criteria (10 listed)
- Diagnosis of cardiovascular disease.
- Diagnosis of diabetes mellitus.
- Diagnosis of chronic kidney disease.
- Diagnosis of familial hypercholesterolemia.
- Incapable of providing informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
1 secondary outcome
Identification of wearable data that improve cardiovascular disease risk prediction without clinical key inputs
Time frame: After 7-day wearable data collection period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petra Stute, Prof. principal investigator
University Hospital of Bern, Department of Gynecological Endocrinology & Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Menopause, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Stute, Prof. (+41 31 632 1010, petra.stute@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in CVD Risk Prediction Uncertainty Using Wearable Data (time frame: After 7-day wearable data collection period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025; AzTrials last refreshed its copy on 1 Nov 2026.