Cardiovascular Diseases (CVD)BEACON-HEARTNCT07401550
Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.
An observational study of Cardiovascular Diseases (CVD) and Cardiovascular Disease Prevention, run by University College Dublin at 1 site in Ireland.
Trial summary
This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases (CVD), Cardiovascular Disease Prevention, Cardiovascular Disease Risk Factor
- How many people
- 100 participants
- Where
- 1 siteIreland
- Study dates
- 9 Dec 2025to Dec 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will primarily include patients with moderate or poor cardiovascular health who have been diagnosed with atherosclerosis and other cardiovascular disease. A smaller proportion of individuals with good cardiovascular health, without diagnosed cardiovascular disease, will also be recruited.
Who may be able to join
- Adults aged 18 years, or older
- Internet access
- Possession of a smartphone compatible with the Fitbit mobile app
Who cannot join
- Pregnancy
- Unstable medical condition
- Inability to provide informed consent
- Mental or cognitive impairment precluding adherence to study protocol
- Smartwatch cannot be worn, (e.g., allergic reactions), or cannot be worn in accordance with manufacturer guidelines (e.g., amputation, dark tattoos at wrist)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beacon Hospital
Dublin, Dublin
Andrew Stone, +353 1 650 4881, andrew.stone@beaconhospital.ie
About this study
Official title: Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study.
This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.
Read the detailed description
Participants will be provided with a Fitbit Charge 6 to wear continuously for six-months. These wearable data will be collected via Fitabase (Small Steps Labs LLC) for the duration of the study.
At baseline, mid-point (three months), and end-point (six months), participants will undergo a clinical cardiovascular health assessment and Life's Essential 8 score will be calculated. Life's Essential 8, established by the American Heart Association, is a composite metric comprising four Health Behaviours and four Health Factors, and provides individuals with a score ranging from 0 (poor health) to 100 (optimal health). Life's Essential 8 health tiers are defined as 'Low' (<50), 'Moderate' (50-79), and 'High' (80-100). Alongside Life's Essential 8, during each clinical assessment, four patient-reported outcome measures will be collected: EQ-5D-5L, International Physical Activity Questionnaire, Patient Health Questionnaire 9, and Generalized Anxiety Disorder 7.
Participants will also complete patient-reported outcome measures online once per week for the duration of the study. These include the Modified Wisconsin Upper Respiratory Symptom Scale (WURSS), Alcohol Intake Questionnaire, Single-Item Sleep Quality Scale (SQS), Patient Health Questionnaire 4 (PHQ-4), and the two-item Modified Hooper Questionnaire for stress and fatigue. Once per month they will complete the Pittsburgh Sleep Quality Index (PSQI).
- Conditions
- Cardiovascular Diseases (CVD), Cardiovascular Disease Prevention, Cardiovascular Disease Risk Factor, Coronary Artery Disease (CAD)
- Keywords
- wearables, wearable devices, cardiovascular health, cardiovascular disease, wearable technology, fitbit, fitabase, remote monitoring, cardiovascular disease prevention, cardiovascular risk reduction, digital biomarker, coronary artery disease
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
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 |
|---|---|---|
| Patients with cardiovascular disease and healthy individuals | A single prospective cohort will be recruited, comprising predominantly individuals with atherosclerotic cardiovascular disease. Patients with mild, moderate and severe ASCVD will be recruited, including patients from cardiac rehabilitation physiotherapy classes and post-operative percutaneous coronary intervention (PCI) patients. A sub-group with good cardiovascular health - without diagnosed cardiovascular disease - will also be recruited as part of this cohort to facilitate analysis across the full spectrum of cardiovascular health and development of statistical models for cardiovascular health assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-Sectional Association of Wearable Biometrics with Cardiovascular Health
The strength and direction of the associations between wearable-derived biometric data (e.g., heart rate, sleep, step count) and cardiovascular health, quantified using Life's Essential 8 score and each of its individual components. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health. Clinical cardiovascular assessments will be paired with wearable biometric data from a window of ±2 weeks surrounding the clinical visit date.
Measured: Baseline, Month 3, and Month 6
Longitudinal Association of Changes in Wearable Biometrics with Changes in Cardiovascular Health
The strength and direction of the association between changes in wearable-derived biometrics and corresponding changes in cardiovascular health, quantified using Life's Essential 8 score and each of its components, assessed over time both within and between individuals. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health.
Measured: Between assessments of cardiovascular health from baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.
Secondary outcomes (4)
Classification Performance for Life's Essential 8 Tier
Model classification performance for discriminating between Life's Essential 8 cardiovascular health tiers using wearable-derived biometrics, with and without partial imputation of Life's Essential 8 components which are measurable by point-of-care testing (diet, nicotine use, HbA1c, lipid profile, BMI, blood pressure). Life's Essential 8 tiers are defined as 'Low' (>50), 'Moderate' (50-79), and 'High' (80-100).
Measured: Baseline, Month 3, Month 6.
Prediction Accuracy of Change in Life's Essential 8 Score
Statistical model performance in estimating the direction and the magnitude of change in Life's Essential 8 score between assessment timepoints, compared with observed scores. A 10-point change in Life's Essential 8 score is clinically significant.
Measured: From baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.
Cross-Sectional Correlation of Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease
The strength and direction of inter-individual correlation between wearable-derived biometric data and patient-reported outcome measures of alcohol intake, sleep, stress and fatigue, illness, anxiety and depression, physical activity, and quality of life.
Measured: Baseline, Month 3, Month 6.
Longitudinal Correlation of Weekly and Monthly Changes in Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease
The strength and direction of intra-individual correlation between wearable-derived biometric data and patient-reported outcome measures of alcohol intake, sleep, stress and fatigue, illness, anxiety and depression, physical activity, and quality of life.
Measured: Baseline through Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start9 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Beacon Hospital, Ireland
- Responsible party
- Principal investigator, Rory Lambe, University College Dublin
- Investigators
- Rory Lambe, Principal investigator, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401550
- Sponsor's protocol ID
- BEA0247
- Acronym
- BEACON-HEART
- Status last verified
- Feb 2026
- First submitted
- 7 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07401550
- Acronym / sponsor ID
- BEACON-HEART / BEA0247
- Conditions
- Cardiovascular Diseases (CVD), Cardiovascular Disease Prevention, Cardiovascular Disease Risk Factor, Coronary Artery Disease (CAD)
- Keywords
- wearables, wearable devices, cardiovascular health, cardiovascular disease, wearable technology, fitbit, fitabase, remote monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Beacon Hospital, Ireland
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.
Detailed description
Participants will be provided with a Fitbit Charge 6 to wear continuously for six-months. These wearable data will be collected via Fitabase (Small Steps Labs LLC) for the duration of the study.
At baseline, mid-point (three months), and end-point (six months), participants will undergo a clinical cardiovascular health assessment and Life's Essential 8 score will be calculated. Life's Essential 8, established by the American Heart Association, is a composite metric comprising four Health Behaviours and four Health Factors, and provides individuals with a score ranging from 0 (poor health) to 100 (optimal health). Life's Essential 8 health tiers are defined as 'Low' (<50), 'Moderate' (50-79), and 'High' (80-100). Alongside Life's Essential 8, during each clinical assessment, four patient-reported outcome measures will be collected: EQ-5D-5L, International Physical Activity Questionnaire, Patient Health Questionnaire 9, and Generalized Anxiety Disorder 7.
Participants will also complete patient-reported outcome measures online once per week for the duration of the study. These include the Modified Wisconsin Upper Respiratory Symptom Scale (WURSS), Alcohol Intake Questionnaire, Single-Item Sleep Quality Scale (SQS), Patient Health Questionnaire 4 (PHQ-4), and the two-item Modified Hooper Questionnaire for stress and fatigue. Once per month they will complete the Pittsburgh Sleep Quality Index (PSQI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiovascular disease and healthy individuals | – | –A single prospective cohort will be recruited, comprising predominantly individuals with atherosclerotic cardiovascular disease. Patients with mild, moderate and severe ASCVD will be recruited, including patients from cardiac rehabilitation physiotherapy classes and post-operative percutaneous coronary intervention (PCI) patients. A sub-group with good cardiovascular health - without diagnosed cardiovascular disease - will also be recruited as part of this cohort to facilitate analysis across the full spectrum of cardiovascular health and development of statistical models for cardiovascular health assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will primarily include patients with moderate or poor cardiovascular health who have been diagnosed with atherosclerosis and other cardiovascular disease. A smaller proportion of individuals with good cardiovascular health, without diagnosed cardiovascular disease, will also be recruited.
Key inclusion criteria (3 listed)
- Adults aged 18 years, or older
- Internet access
- Possession of a smartphone compatible with the Fitbit mobile app
Key exclusion criteria (5 listed)
- Pregnancy
- Unstable medical condition
- Inability to provide informed consent
- Mental or cognitive impairment precluding adherence to study protocol
- Smartwatch cannot be worn, (e.g., allergic reactions), or cannot be worn in accordance with manufacturer guidelines (e.g., amputation, dark tattoos at wrist)
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
Cross-Sectional Association of Wearable Biometrics with Cardiovascular Health
Time frame: Baseline, Month 3, and Month 6
The strength and direction of the associations between wearable-derived biometric data (e.g., heart rate, sleep, step count) and cardiovascular health, quantified using Life's Essential 8 score and each of its individual components. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health. Clinical cardiovascular assessments will be paired with wearable biometric data from a window of ±2 weeks surrounding the clinical visit date.
Longitudinal Association of Changes in Wearable Biometrics with Changes in Cardiovascular Health
Time frame: Between assessments of cardiovascular health from baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.
The strength and direction of the association between changes in wearable-derived biometrics and corresponding changes in cardiovascular health, quantified using Life's Essential 8 score and each of its components, assessed over time both within and between individuals. Life's Essential 8 is measured on a scale from 0 to 100, with higher scores representing better cardiovascular health.
4 secondary outcomes
Classification Performance for Life's Essential 8 Tier
Time frame: Baseline, Month 3, Month 6.
Prediction Accuracy of Change in Life's Essential 8 Score
Time frame: From baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.
Cross-Sectional Correlation of Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease
Time frame: Baseline, Month 3, Month 6.
Longitudinal Correlation of Weekly and Monthly Changes in Wearable Biometrics with Patient-Reported Psychosocial and Behavioural Risk Factors of Cardiovascular Disease
Time frame: Baseline through Month 6
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 10 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Rory Lambe principal investigator
University College Dublin
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 (CVD) and Cardiovascular Disease Prevention, run by University College Dublin at 1 site in Ireland.
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 5 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 10 Feb 2026. 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 Ireland. 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 Rory Lambe (+353 1 716 3442, rory.lambe@ucdconnect.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-Sectional Association of Wearable Biometrics with Cardiovascular Health (time frame: Baseline, Month 3, and Month 6). The study lists 2 primary outcomes in all. 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 10 Feb 2026.