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Feasibility of integrating genetic risk and digital health tools for cardiovascular prevention: the FitPreV protocol
Diego Maria Tona1, Martina Porcelli1, Matteo Di Pumpo1
1Section of Hygiene, University Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.
Insights
This study explores integrating genetic risk scores and wearable devices for cardiovascular disease prevention in Italy. It assesses the feasibility and patient acceptance of these tools in primary care settings.
Area of Science:
- Cardiovascular disease prevention
- Digital health technologies
- Genetic risk assessment
Background:
- Cardiovascular diseases (CVDs) are a leading global cause of death.
- Both genetic susceptibility and modifiable risk factors contribute to CVD burden.
- Polygenic risk scores (PRS) and wearable health devices (WHDs) offer new prevention avenues, but their integration feasibility is unevaluated.
Purpose of the Study:
- To assess the feasibility of implementing PRS and WHDs in cardiovascular primary prevention.
- To evaluate the acceptability, practicality, and barriers to adoption in Italian general practice for individuals with metabolic syndrome.
- To generate evidence for personalized prevention strategies in national primary care.
Main Methods:
- A pilot, four-arm randomized controlled feasibility study (FitPreV) involving 120 adults (40-69 years) with metabolic syndrome.
- Participants assigned to standard counseling, counseling + WHD, counseling + PRS, or counseling + PRS + WHD.
- Feasibility assessed via recruitment, retention, acceptability, and readiness; secondary outcomes include lifestyle, lipid profiles, and CVD risk.
Main Results:
- The study is designed to generate evidence on the operational feasibility and acceptability of integrating genetic risk assessment and digital monitoring tools.
- It will provide insights into real-world implementation challenges within general practice settings.
- Foundational data will guide larger-scale effectiveness trials for personalized cardiovascular prevention.
Conclusions:
- The FitPreV study will provide crucial evidence on the feasibility of integrating PRS and WHDs into primary cardiovascular prevention.
- Findings will inform the implementation of personalized prevention approaches within national healthcare systems.
- This research supports the advancement of digital health and genetic tools in public health strategies.
Background:
Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide. While a substantial proportion of CVD burden is attributable to modifiable risk factors, individual genetic susceptibility also contributes significantly. Polygenic risk scores (PRS) have emerged as promising tools to quantify inherited cardiovascular risk, while digital health technologies, such as wearable health devices (WHDs), provide new opportunities for continuous lifestyle monitoring However, the feasibility of integrating PRS and WHDs into primary prevention within public healthcare systems has not yet been systematically evaluated.
Objective:
The FitPreV study aims to assess the feasibility of implementing PRS and WHDs in cardiovascular primary prevention among individuals with metabolic syndrome in the Italian National Health Service (SSN), focusing on their acceptability, practicality, and barriers to adoption in general practice.
Methods:
FitPreV is a pilot, four-arm, randomized controlled feasibility study involving 120 adults aged 40-69 years diagnosed with metabolic syndrome and an estimated 10-year CVD risk between 2.5 and 10%. Participants will be randomly assigned to: (1) standard counseling; (2) counseling plus WHD; (3) counseling plus PRS; or (4) counseling plus both PRS and WHD. Data will be collected at baseline, 1, 6, and 12 months. Feasibility indicators include recruitment and retention rates, acceptability, burden and structural readiness. Secondary outcomes include changes in lifestyle behaviors, lipid profiles and cardiovascular risk (SCORE2 algorithm).
Expected Results:
The study will generate evidence on the operational feasibility and acceptability of integrating genetic risk assessment and digital monitoring tools into primary cardiovascular prevention within general practice settings.
Conclusions:
By evaluating real-world implementation challenges, FitPreV will provide foundational evidence to guide larger-scale effectiveness trials studying personalized prevention approaches into national primary care settings.
Trial Registration:
https://clinicaltrials.gov/study/NCT06911294, identifier: NCT06911294.
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