Innovative approaches for personalised cardiovascular prevention: multicentre randomised controlled study and multidisciplinary evalutation for a National Health Service implementation

Cardiovascular diseases (CVDs), which mainly result from an interaction between lifestyle and genetic determinants, contribute to the largest burden of mortality and morbidity in Europe and worldwide. It has been suggested that genetic influence derives from a combined effect of many genetic variants, which can be assessed by computing polygenic risk scores (PRS) to estimate the risk of developing CVDs and to inform personalised prevention strategies. Personalisation drives innovation in health research and development in health systems with limited resources and under pressure due to an ageing population and increasing health needs. A shift from one-size-fits-all treatment of established diseases toward disease prevention and early diagnosis approaches has been envisioned to ensure the sustainability of European health systems. However, no studies have yet evaluated the value of PRS risk prediction alone or in combination with digital technologies to promote lifestyle changes aiming at CVD risk reduction.
INNOPREV (the Innovative approaches for personalised cardiovascular prevention: a multicentre randomised controlled study and multidisciplinary evaluation for National Health Service implementation) aims to provide evidence and guidance to the Italian national health service (NHS) for the take-up of innovative approaches for personalised primary preventive interventions for CVD. We will evaluate if the use of innovative digital tools to gather information on lifestyle and genetic determinants in the primary prevention setting may change the behaviours and the CVD risk of individuals. We will further analyse what this can mean in terms of health outcomes and system efficiency using the health technology assessment approach. For this purpose, the consortium will set up the INNOPREV trial in 3 metropolitan areas (Catania, Palermo, and Rome) including 1020 participants between 40 and 69 years at a high 10-year risk profile of CVD. Enrolled individuals will fill out a lifestyle questionnaire on socioeconomic status, smoking status, alcohol consumption, dietary pattern, and physical activity that will define the individual lifestyle pattern. Participants will be randomized to four interventions: (1) traditional risk assessment at baseline; (2) intervention 1 plus dedicated app and wearable device; (3) intervention 1 plus receiving baseline CVD PRS; (4) intervention 1 plus dedicated app and wearable device and baseline CVD PRS. The primary outcome is the marginal effect of these interventions on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. Our results will be complemented by a multidisciplinary assessment of the implementation of these technologies in the NHS context. Expected findings will allow us to evaluate the impact of innovative preventive interventions that combine ¿omic¿ background risk with the use of digital and m-health on health promotion. The translational efforts and the results will contribute to providing high-level evidence on the take up of personalized innovative approaches for CVD prevention, which might also reduce citizens' disability and related costs. In a broader perspective, the implications of INNOPREV might be extended to the prevention of other chronic diseases with similar patterns of lifestyles. Four partners (FPG, AOUPCT, AOUPPA, UNIPG), with documented expertise in personalized medicine and health care system sustainability, will be involved in the project.