Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics. (BEACON-HEART)

February 3, 2026 updated by: Rory Lambe, University College Dublin

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Adults aged 18 years, or older
  • Internet access
  • Possession of a smartphone compatible with the Fitbit mobile app

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 3, and Month 6
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.
Between assessments of cardiovascular health from baseline to Month 3, Month 3 to Month 6, and baseline to Month 6.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Classification Performance for Life's Essential 8 Tier
Time Frame: Baseline, Month 3, Month 6.
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).
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.
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.
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.
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.
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
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.
Baseline through Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Dublin

Collaborators

Beacon Hospital, Ireland

Investigators

  • Principal Investigator: Rory Lambe, University College Dublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEA0247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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