Genetic Risk Scores and Wearables for CVD Prevention: Insights from the FItPreV Trial

Abstract Introduction Cardiovascular diseases (CVDs) are the leading cause of death worldwide. Despite advances in prevention, a substantial burden remains due to modifiable risk factors. Individuals with metabolic syndrome are at particularly high risk. Personalized strategies, such as polygenic risk scores (PRS) and wearable health devices (WHDs), may enhance prevention efforts. The FItPreV study aims to evaluate the feasibility and preliminary impact of these tools in CVD primary prevention among citizens with metabolic syndrome. ClinicalTrials.gov Id: NCT06911294 Methods FItPreV is a pilot randomized controlled trial conducted in seven general practices in Rome. We completed the enrollment of 116 citizens aged 40-69 years with metabolic syndrome. Participants were randomized into four groups: usual care, digital intervention (WHDs), genetic intervention (PRS), and combined intervention (PRS and WHDs). Follow-up assessments are scheduled at 6 and 12 months. Feasibility indicators include recruitment, attendance rates, physicians’ experience, participants’ perceptions, and self-efficacy. Secondary objectives include preliminary evaluation of changes in lipid profiles and lifestyle behaviors. Results Of the 116 participants enrolled, 70 (54%) have completed the 6-month follow-up. Among them, 85% reported satisfaction with the use of PRS and WHDs, without expressing concerns regarding genetic information. Preliminary data show that 78% found WHDs helpful in improving lifestyle habits. However, 65% of general practitioners reported challenges in integrating these new practices due to limited staff and technological resources. Conclusions Preliminary results from the FItPreV study show good feasibility and high acceptability of PRS and WHDs among citizens with metabolic syndrome. However, structural barriers in primary care must be addressed to enable wider implementation. Final results after follow-up will provide further evidence on clinical outcomes and system integration. Key messages • Personalized tools like PRS and wearables are feasible and well accepted for CVD prevention. • Structural barriers in primary care must be addressed to integrate personalized prevention tools.