Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention (FITPREV)

August 4, 2025 updated by: Roberta Pastorino, Catholic University of the Sacred Heart

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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 Criteria:

  • Diabetes:
  • Familial hypercholesterolemia;
  • Previous cardiovascular events.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention - Standard of Care
Participants will receive traditional lifestyle advices in order to reduce the risk.
Experimental: Genetic testing - PRS
Arm Description: Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices.
Behavioral: Polygenic Risk Score
genetic test for the evaluation of cardiovascular risk
Experimental: Experimental: Digital intervention - app and wearable device
Arm Description: Participants will receive an app and a wearable device for the evaluation of various parameters.
Behavioral: Digital app and wearable device
a wearable device connected with its app
Experimental: Digital intervention and genetic testing - PRS
Arm Description: Participants will receive both app and wearable device and PRS information
Behavioral: Polygenic Risk Score
genetic test for the evaluation of cardiovascular risk
Behavioral: Digital app and wearable device
a wearable device connected with its app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 year
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).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Lifestyle Category
Time Frame: 12 months
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.
12 months
Modification of the Lipid Profile
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Estimated)

February 10, 2026

Study Completion (Estimated)

September 10, 2026

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7700, 7885-7890

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Heart Disease

Clinical Trials on Polygenic Risk Score

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe