Status:
RECRUITING
Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
40-69 years
Phase:
NA
Brief 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...
Detailed Description
This study aims to evaluate the feasibility and secondarily efficacy of disclosing cardiovascular genetic risk-in the setting of a general practitioner's office-in the promotion of healthier lifestyle...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Diabetes:
- Familial hypercholesterolemia;
- Previous cardiovascular events.
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06911294
Start Date
February 10 2025
End Date
September 10 2026
Last Update
August 5 2025
Active Locations (7)
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1
Studio Antonaci
Rome, Italy, Italy
2
Studio Colletti
Rome, Italy
3
Studio Maggiori
Rome, Italy
4
Studio Mammucari
Rome, Italy