Coronary Heart DiseaseFITPREVNCT06911294
Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention
A study testing Polygenic Risk Score and Digital app and wearable device in people with Coronary Heart Disease, run by Catholic University of the Sacred Heart at 7 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Polygenic Risk Score and Digital app and wearable device
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesItaly
- Study dates
- 10 Feb 2025to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetes:
- Familial hypercholesterolemia;
- Previous cardiovascular events.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
Studio Antonaci
Rome, Italy
Luciano Antonaci, +393356574532, dott.antonaci@gmail.com
- Recruiting
Studio Colletti
Rome
Roberto Colletti, +393933062969, dr.collettimg@gmail.com
- Recruiting
Studio Maggiori
Rome
Enrica Maggiori, +393392334787, enricamaggiori@libero.it
- Recruiting
Studio Mammucari
Rome
Massimo Mammucari, +393357685440, massimo.mammucari@libero.it
- Recruiting
Studio Marra
Rome
Giulia A Marra, 3489312237, giuliaantonia.marra@gmail.com
- Recruiting
Studio Paoletti
Rome
Filippo Paoletti, +393336479293, filippopaoletti.an@gmail.com
- Recruiting
Studio Pasca
Rome
Giulio FM Pasca, +393484267755, giuliofm.pasca@gmail.com
About this study
Official title: Feasibility of InnovaTive Approaches for Personalized Cardiovascular PREVention: Randomized Controlled Pilot Trial and Multidisciplinary Evaluation for National Health Service Implementation
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.
Read more
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.
Read the 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 behaviors.
The enrollment period will last 6 months, with each participant taking part in the study for 12. There are three key time points in the study, T0 or baseline (enrollment phase), T1 or disclosure visit after one month, T2 intermediate visit(after six months) and T3 or final visit at 12 months. At enrollment, participants will be classified into risk categories based on cardiovascular risk using the SCORE-2 or SCORE 2-OP tool. Individuals aged 40-69, without diabetes or congenital hypercolesterolemia, with a SCORE-2 between 2.5% and 10% and a diagnosys of metabolic syndrome according to the American Hearth Association Criteria will be enrolled.
Once enrolled (T0), all participants will sign the informed consent form and undergo a comprehensive assessment, which includes:
- Completing a questionnaire on socioeconomic status, area of residence, and lifestyle, using the Life's Essential 8 tool. The questionnaire will cover smoking status, alcohol consumption, dietary pattern, sleep pattern, and physical activity. Participants will be classified into favorable, intermediate, or unfavorable individual lifestyle patterns according to the Life's Essential 8 score.
- Blood analysis will be performed to evaluate the lipid profile, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
At T1, a disclosure visit will be conducted to explain the assigned lifestyle category, share the results of the blood tests, and provide information on the expected interventions based on the assigned group.
The questionnaire will be administered at T0, T2, and T3. Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3.
Feasibility Questionnaire: Both participants and medical professionals will complete a questionnaire on the acceptability and feasibility of the intervention.
- Conditions
- Coronary Heart Disease
- Being tested
- Polygenic Risk Score, Digital app and wearable device
- Keywords
- coronary artery disease, Polygenic Risk Score
- Medical subject headings
- Coronary Disease, Coronary Artery Disease, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygenic Risk ScoreBehavioural
genetic test for the evaluation of cardiovascular risk
Digital app and wearable deviceBehavioural
a wearable device connected with its app
| Study group | Role | What they receive |
|---|---|---|
| No intervention - Standard of Care | No intervention | Participants will receive traditional lifestyle advices in order to reduce the risk. |
| Genetic testing - PRS | Experimental | Arm Description: Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices. Receives: Behavioral: Polygenic Risk Score |
| Experimental: Digital intervention - app and wearable device | Experimental | Arm Description: Participants will receive an app and a wearable device for the evaluation of various parameters. Receives: Behavioral: Digital app and wearable device |
| Digital intervention and genetic testing - PRS | Experimental | Arm Description: Participants will receive both app and wearable device and PRS information Receives: Behavioral: Polygenic Risk Score; Behavioral: Digital app and wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility for the patients
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).
Measured: 1 year
Feasibility for the General Practitioners
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).
Measured: 1 year
Secondary outcomes (2)
Change in the Lifestyle Category
The lifestyle category will be measured using the Life's Essential 8 tool. A change will be considered achieved if there is a shift towards a more favorable lifestyle category.
Measured: 12 months
Modification of the Lipid Profile
We will evaluate whether there is a change in the lipid profile compared to the baseline value. The modification of the lipid profile can also be considered as an indicator of the modification of the cardiovascular risk profile measured with the SCORE 2 charts.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start10 Feb 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberta Pastorino, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911294
- Sponsor's protocol ID
- 7700, 7885-7890
- Acronym
- FITPREV
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.
PubMed 35766027Tona DM, Porcelli M, Di Pumpo M, Cuoco F, Cuoco MF, Terenzi L, Antonaci L, Maggiori E, Colletti R, Guiducci E, Mammucari M, Paoletti F, Pasca G, Marra GA, Carbone D, Pasciuto T, Sanna T, Liuzzo G, Franceschini E, Villarini A, Pocetta G, de Waure C, Boccia S, Pastorino R. Feasibility of integrating genetic risk and digital health tools for cardiovascular prevention: the FitPreV protocol. Front Public Health. 2026 May 29;14:1800961. doi: 10.3389/fpubh.2026.1800961. eCollection 2026.
PubMed 42293583
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of InnovaTive Approaches for Personalized Cardiovascular PREVention: Randomized Controlled Pilot Trial and Multidisciplinary Evaluation for National Health Service Implementation
- ClinicalTrials.gov ID
- NCT06911294
- Acronym / sponsor ID
- FITPREV / 7700, 7885-7890
- Conditions
- Coronary Heart Disease
- Keywords
- coronary artery disease, Polygenic Risk Score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 behaviors.
The enrollment period will last 6 months, with each participant taking part in the study for 12. There are three key time points in the study, T0 or baseline (enrollment phase), T1 or disclosure visit after one month, T2 intermediate visit(after six months) and T3 or final visit at 12 months. At enrollment, participants will be classified into risk categories based on cardiovascular risk using the SCORE-2 or SCORE 2-OP tool. Individuals aged 40-69, without diabetes or congenital hypercolesterolemia, with a SCORE-2 between 2.5% and 10% and a diagnosys of metabolic syndrome according to the American Hearth Association Criteria will be enrolled.
Once enrolled (T0), all participants will sign the informed consent form and undergo a comprehensive assessment, which includes:
- Completing a questionnaire on socioeconomic status, area of residence, and lifestyle, using the Life's Essential 8 tool. The questionnaire will cover smoking status, alcohol consumption, dietary pattern, sleep pattern, and physical activity. Participants will be classified into favorable, intermediate, or unfavorable individual lifestyle patterns according to the Life's Essential 8 score.
- Blood analysis will be performed to evaluate the lipid profile, including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides.
At T1, a disclosure visit will be conducted to explain the assigned lifestyle category, share the results of the blood tests, and provide information on the expected interventions based on the assigned group.
The questionnaire will be administered at T0, T2, and T3. Blood analysis and cardiovascular profile evaluation will be conducted at both T0 and T3.
Feasibility Questionnaire: Both participants and medical professionals will complete a questionnaire on the acceptability and feasibility of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No intervention - Standard of Care | No intervention | –Participants will receive traditional lifestyle advices in order to reduce the risk. |
| Genetic testing - PRS | Experimental | Behavioral: Polygenic Risk ScoreArm Description: Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices. |
| Experimental: Digital intervention - app and wearable device | Experimental | Behavioral: Digital app and wearable deviceArm Description: Participants will receive an app and a wearable device for the evaluation of various parameters. |
| Digital intervention and genetic testing - PRS | Experimental | Behavioral: Polygenic Risk Score, Behavioral: Digital app and wearable deviceArm Description: Participants will receive both app and wearable device and PRS information |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- Diabetes:
- Familial hypercholesterolemia;
- Previous cardiovascular events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polygenic Risk Scoregenetic test for the evaluation of cardiovascular risk | Behavioural | Digital intervention and genetic testing - PRS, Genetic testing - PRS |
| Digital app and wearable devicea wearable device connected with its app | Behavioural | Digital intervention and genetic testing - PRS, Experimental: Digital intervention - app and wearable device |
Primary outcome
Feasibility for the patients
Time frame: 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
Time frame: 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).
2 secondary outcomes
Change in the Lifestyle Category
Time frame: 12 months
Modification of the Lipid Profile
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 35766027Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.
- Derived from this study: PubMed 42293583Tona DM, Porcelli M, Di Pumpo M, Cuoco F, Cuoco MF, Terenzi L, Antonaci L, Maggiori E, Colletti R, Guiducci E, Mammucari M, Paoletti F, Pasca G, Marra GA, Carbone D, Pasciuto T, Sanna T, Liuzzo G, Franceschini E, Villarini A, Pocetta G, de Waure C, Boccia S, Pastorino R. Feasibility of integrating genetic risk and digital health tools for cardiovascular prevention: the FitPreV protocol. Front Public Health. 2026 May 29;14:1800961. doi: 10.3389/fpubh.2026.1800961. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygenic Risk Score and Digital app and wearable device in people with Coronary Heart Disease, run by Catholic University of the Sacred Heart at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberta Pastorino (+393495624174, roberta.pastorino@unicatt.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility for the patients (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06911294, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.