Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention

Condition(s) studied

Investigational drug(s) / intervention(s)

Polygenic Risk Score: genetic test for the evaluation of cardiovascular risk

Digital app and wearable device: a wearable device connected with its app

Study summary

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.

Eligibility

Primary outcome measure(s)

• Feasibility for the patients — 1 year
  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 — 1 year
  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).

Trial sites (7)

More Catholic University of the Sacred Heart trials in Italy

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