NCT06911294Recruiting
Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention
Feasibility of InnovaTive Approaches for Personalized Cardiovascular PREVention: Randomized Controlled Pilot Trial and Multidisciplinary Evaluation for National Health Service Implementation
Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 28 Mar 2025
- Start date
- 10 Feb 2025
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- Catholic University of the Sacred Heart
- Diseases
- Coronary artery disease
- NCT number
- NCT06911294
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 10 Feb 2025 to the primary completion date, 10 Feb 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cardiovascular events.
Other illness
- Diabetes:
Other
- Familial hypercholesterolemia;
Who the study is looking for
- Age 40-69 years;
- 10 year cardiovascular risk score SCORE2 between 2.5% and 10%.
- Diagnosis of metabolic syndrome according to the American Heart Association criteria , defined as the presence of three or more of the following:
- 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.
- Low HDL cholesterol levels (less than 40 mg/dL in men and less than 50 mg/dL in women) or use of cholesterol-lowering medication.
- Elevated blood pressure: systolic ≥130 mmHg or diastolic ≥85 mmHg, or use of antihypertensive medication.
- Elevated fasting blood glucose: ≥100 mg/dL or use of glucose-lowering medication.
Age in the registry: 40 years to 69 years · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Studio Paoletti Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Studio Pasca Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Studio Antonaci Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Studio Colletti Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Studio Mammucari Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Studio Maggiori Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Studio Marra Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.