Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention

Official title

Feasibility of InnovaTive Approaches for Personalized Cardiovascular PREVention: Randomized Controlled Pilot Trial and Multidisciplinary Evaluation for National Health Service Implementation

Overview

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.

Interventions

• 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

Primary outcome measures

• Feasibility for the patients [Time frame: 1 year]
• Feasibility for the General Practitioners [Time frame: 1 year]

Secondary outcome measures (2)

• Change in the Lifestyle Category [Time frame: 12 months]
• Modification of the Lipid Profile [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Italy · 7 centers

• Studio Antonaci — Rome
• Studio Colletti — Rome
• Studio Maggiori — Rome
• Studio Mammucari — Rome
• Studio Marra — Rome
• Studio Paoletti — Rome
• Studio Pasca — Rome

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.000000000000 PMID 35766027
• Tona 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 Publ PMID 42293583

Identifiers

NCT: NCT06911294 · 7700, 7885-7890

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗