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Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention

Study acronym: FITPREV
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 5, 2025 (before its estimated February 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Enrollment target: 200 to 120v3
  2. Minor Site details revised at 1 of 7 sites
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 3 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06911294
Lead Sponsor Catholic University of the Sacred Heart
Conditions
(from sponsor)
Coronary Heart Disease
Related terms Coronary Artery Disease, Coronary Disease, Genetic Risk Score
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov