Personalised cardiovascular prevention in primary care: feasibility results from the FitPreV trial

Background

Cardiovascular disease prevention requires strategies for individuals at elevated metabolic risk. Polygenic risk scores (PRS) may refine risk stratification, while wearable health devices (WHDs) may support lifestyle change through self-monitoring. FitPreV assessed the feasibility and acceptability of integrating PRS-based risk communication and WHD-supported behavioural monitoring into primary cardiovascular prevention within the Italian NHS.

Methods

FitPreV (ClinicalTrials.gov NCT06911294) is a pilot RCT conducted in seven general practices in Rome. Adults aged 40–69 with metabolic syndrome and 10-year cardiovascular risk of 2.5–10% were randomized to standard counselling, WHD-supported, PRS-informed, or combined intervention. Feasibility was assessed through recruitment, retention and eCRF completeness. Acceptability, participant-reported outcomes, blood tests and clinical measurements were evaluated at 12 months.

Results

Of 160 eligible individuals, 120 were enrolled (recruitment rate of 75%). Overall, 82 participants completed follow-up, resulting in a retention rate of 68.3%, while eCRF completeness exceeded 90%. PRS disclosure was well accepted: 58.5% reported no anxiety, and 70.7% stated that PRS information motivated preventive behaviours. WHD use was well tolerated, with 56.4% reporting use for ≥9 months. GP acceptability was high, with 89% considering PRS integrable into practice, although self-efficacy in using PRS remained limited. Participants reported improved lifestyle behaviours, with no significant differences across arms.

Conclusions

FitPreV suggests that integrating PRS-informed risk communication and WHD-supported self-monitoring into primary cardiovascular prevention is feasible and acceptable. These findings support a definitive trial and highlight the need to strengthen providers’ confidence in using innovative prevention tools.

Funding

Next Generation EU, Italian Ministry of University and Research (grant no. P20229BC5H).

Key messages

• Personalised cardiovascular prevention using polygenic risk scores and wearable devices can be feasibly integrated into routine primary care.

• Before wider health-system adoption, a definitive trial is needed with stronger strategies to improve participant retention.