Actively Recruiting
Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention
Led by Catholic University of the Sacred Heart · Updated on 2025-08-05
120
Participants Needed
7
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 69 years
- 10 year cardiovascular risk score (SCORE2) between 2.5% and 10%
- Diagnosis of metabolic syndrome based on American Heart Association criteria, including at least three of the following:
- Central or abdominal obesity (waist circumference > 40 inches / 102 cm in men; > 35 inches / 89 cm in women)
- Elevated triglycerides (≥150 mg/dL) or medication for hypertriglyceridemia
- Low HDL cholesterol (<40 mg/dL in men; <50 mg/dL in women) or cholesterol-lowering medication use
- Elevated blood pressure (systolic ≥130 mmHg or diastolic ≥85 mmHg) or antihypertensive medication use
- Elevated fasting blood glucose (≥100 mg/dL) or use of glucose-lowering medication
You will not qualify if you...
- Diagnosis of diabetes
- Familial hypercholesterolemia
- Previous cardiovascular events
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Studio Antonaci
Rome, Italy, Italy
Actively Recruiting
2
Studio Colletti
Rome, Italy
Actively Recruiting
3
Studio Maggiori
Rome, Italy
Actively Recruiting
4
Studio Mammucari
Rome, Italy
Actively Recruiting
5
Studio Marra
Rome, Italy
Actively Recruiting
6
Studio Paoletti
Rome, Italy
Actively Recruiting
7
Studio Pasca
Rome, Italy
Actively Recruiting
Research Team
R
Roberta Pastorino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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