Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention

NCT06911294 | Recruiting

• 1 other identifier: 7700, 7885-7890
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 7

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 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

Coronary Heart Disease

Keywords

coronary artery disease; Polygenic Risk Score

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  1 year

Secondary Outcomes (2)

• Change in the Lifestyle Category

  12 months

• Modification of the Lipid Profile

  12 months

Study Arms (4)

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.

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.

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

Behavioral: Polygenic Risk Score; Behavioral: Digital app and wearable device

Interventions

Polygenic Risk Score BEHAVIORAL

genetic test for the evaluation of cardiovascular risk

Digital intervention and genetic testing - PRS; Genetic testing - PRS

Digital app and wearable device BEHAVIORAL

a wearable device connected with its app

Digital intervention and genetic testing - PRS; Experimental: Digital intervention - app and wearable device

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40-69 years;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (7)

Studio Antonaci

Rome, Italy, Italy

RECRUITING

Studio Colletti

Rome, Italy

RECRUITING

Studio Maggiori

Rome, Italy

RECRUITING

Studio Mammucari

Rome, Italy

RECRUITING

Studio Marra

Rome, Italy

RECRUITING

Studio Paoletti

Rome, Italy

RECRUITING

Studio Pasca

Rome, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 35766027 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Genetic Risk Score

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Genetic Predisposition to Disease; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Roberta Pastorino

CONTACT

+393495624174; roberta.pastorino@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: February 10, 2025
• Primary Completion: February 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-03

Locations

IT (7)