The goal of the FITPREV (Feasibility of InnovaTive approaches for personalized cardiovascular PREVention: randomized controlled pilot trial and multidisciplinary evaluation for National Health Service implementation) clinical trial is to study the feasibility of innovative approaches( Polygenic Risk Score and health smartwatch) for personalized primary preventive interventions in cardiovascular diseases (CVD). The main questions it aims to answer are:
* Feasibility of a greater study. * Feasibility of the interventions in a realistic setting, such as the medical office of a General Practitioner.
Participants will be randomized in one of the four parallel arms:
* standard of care; * genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS); * digital intervention with a wearable device and its app; * digital intervention and genetic testing
The primary outcomes that are going to be evaluated are patient's and General Practitioners' overall judgment of the study and its feasibility.
Secondarily the efficacy of returning Polygenic Risk Score (PRS) results will be assessed. This will happen on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline.
Age 40-69 years;
10 year cardiovascular risk score SCORE2 between 2.5% and 10%.
Central or abdominal obesity, measured by waist circumference (greater than 40 inches - 102 cm in men and 35 inches - 89 cm in women).
Elevated triglycerides: levels equal to or greater than 150 mg/dL or use of medication for hypertriglyceridemia.
Familial hypercholesterolemia;
Previous cardiovascular events.
Parallel
Polygenic Risk Score
Behavioralgenetic test for the evaluation of cardiovascular risk
Digital app and wearable device
Behaviorala wearable device connected with its app
Feasibility for the patients
Feasibility will be measured scoring the answer to a short questionnaire compiled at the end of the study(Using one open question, a few yes/no questions and some questions with a Likert 5 scale of agreement).
Feasibility for the General Practitioners
Feasibility will be measured scoring the answer to a short questionnaire compiled at the end of the study(Using one open question, a few yes/no questions and some questions with a Likert 5 scale of agreement).
Change in the Lifestyle Category
The lifestyle category will be measured using the Life's Essential 8 tool. A change will be considered achieved if there is a shift towards a more favorable lifestyle category.
Modification of the Lipid Profile
We will evaluate whether there is a change in the lipid profile compared to the baseline value. The modification of the lipid profile can also be considered as an indicator of the modification of the cardiovascular risk profile measured with the SCORE 2 charts.
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