Why the study?
Digital biomarkers are increasingly used across cardiovascular medicine, motivating a systematic review of their clinical utility and major methodological and implementation challenges.
Do digital biomarkers derived from digital health technologies improve clinical utility and outcomes in patients with cardiovascular disease?
Systematic Review (n=32,246)
Do digital biomarkers derived from digital health technologies improve clinical utility and outcomes in patients with cardiovascular disease?
Answers are grounded in this paper and cite their sources.
Digital biomarkers show promise in cardiovascular medicine, particularly for heart failure and arrhythmias, but require robust validation and cost-effectiveness evidence for widespread implementation.
Cardiovascular disease is the leading cause of morbidity and mortality globally, imposing a substantial patient burden. Digital biomarkers derived from digital health technologies enable quantifiable, near-continuous, real-world capture of pathophysiological signals and are increasingly used across cardiovascular medicine. Their growth is often supported by big data analytics, artificial intelligence and connected sensors within the Internet of Things. This scientific statement systematically reviews digital biomarkers, their clinical utility across the cardiovascular care continuum, and summarizes major methodological and implementation challenges. We searched PubMed/MEDLINE, Embase and Scopus for phase III–IV cardiovascular trials published between 1 January 2019 and 1 August 2024 that collected digital biomarkers. We identified 541 records and included 32 trials (40 reports) enrolling 32 246 participants (44.71% women; mean age 66.2 ± 11.0 years). Heart failure was the most frequent target condition (16 trials, 50%), followed by cardiac implantable electronic devices trials (12 trials, 38%). Digital biomarkers included cardiac rhythm and heart rate, blood pressure, body weight, impedance-based measures, haemodynamic pressures, and physical activity and sleep patterns captured using diverse sensor technologies. Methodological quality was good (modal quality score 5; range 3–7), although most trials were unblinded. Current studies suggest potential clinical utility in selected cardiovascular conditions. Implementation remains challenging because of measurement variability, privacy and regulatory requirements, affordability and reimbursement barriers and inequities in access. Robust validation and outcome- and cost-effectiveness evidence are still needed. Registration number: CRD42024573879.
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Corredoira et al. (2026) conducted a systematic review in Cardiovascular disease (n=32,246). Digital biomarkers derived from digital health technologies vs. Usual care or traditional monitoring was evaluated on Clinical utility and methodological quality of digital biomarkers in cardiovascular trials. Digital biomarkers derived from digital health technologies show potential clinical utility in selected cardiovascular conditions, though implementation remains challenging.
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