Personalized HeartCare: Sharing polygenic heart-risk scores to prevent cardiovascular disease
Official title: Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change
Run by Catholic University of the Sacred Heart · NCT06888466 · Data updated 2026-11-12
This pilot tests whether giving hospital staff their polygenic cardiovascular risk score plus in-person personalized coaching helps adults 40+ with low-to-moderate SCORE2 risk improve heart-healthy behaviors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 650 (estimated) |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 1 site (Roma, Italia) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | March 2026 |
| Study ends | December 2026 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT06888466 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are staff members of Fondazione Policlinico Universitario Agostino Gemelli IRCCS aged 40 or older with recent blood tests and low-to-moderate SCORE2 or SCORE2-OP risk who do not have diabetes, familial hypercholesterolemia, or established cardiovascular disease.
✕Probably not a fit
Patients with very high SCORE2/SCORE2-OP risk, diabetes, familial hypercholesterolemia, prior cardiovascular events, or those who are not staff at the participating institution are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm, pre–post pilot enrolls staff from Fondazione Policlinico Universitario Agostino Gemelli IRCCS and uses genetic testing to generate a polygenic risk score (PRS) for cardiovascular disease. Participants complete baseline assessments including the Life's Essential 8 (LE'8) lifestyle questionnaire, clinical measures and recent blood tests (T0), receive PRS disclosure with an in-person consultation and personalized coaching (T1), and return for a final visit at six months (T2). Eligibility targets adults aged 40+ with low-to-moderate SCORE2 or SCORE2-OP risk and excludes those with very high risk, diabetes, familial hypercholesterolemia, or prior cardiovascular events. The main outcome is change in lifestyle behaviors and LE'8 score from baseline to six months, with subgroup analyses by genetic risk level.
Why it matters
Potential benefit: If successful, this approach could motivate lasting lifestyle changes that reduce future cardiovascular risk in people with low-to-moderate conventional risk.
How similar studies have gone: Previous studies disclosing polygenic cardiovascular risk have produced mixed and generally modest behavior changes, so combining PRS disclosure with in-person coaching in this specific clinical staff setting is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria * Traditional cardiovascular risk: The risk will be assessed using SCORE 2 (low risk \< 2.5%, moderate risk between 2.5% and 5%, high risk between 5% and 10%) or SCORE 2-OP (moderate risk \< 7.5%, high risk between 7.5% and 15%). * Blood tests: Participants must have had blood tests performed within the past 6 months. * Age: Participants must be at least 40 years old. Exclusion Criteria * Very high cardiovascular risk, as measured by SCORE 2 (very high risk \> 10%) or SCORE 2-OP (very high risk \> 15%). * Diabetes. * Familial hypercholesterolemia. * Previous cardiovascular events or established CVD
Where it's running
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Dipartimento Universitario di Scienze della Vita e Sanità Pubblica
Roma, Italia, Italy Recruiting
Study contacts
- Study coordinator: Stefania Boccia
- Email: stefania.boccia@policlinicogemelli.it
- Phone: +39 0630154396
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.