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Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention

Study acronym: PHC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 20, 2026 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 2026 to Mar 2026v5
  2. Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS to Catholic University of the Sacred Heartv4 Show 4 more changesShow less
    • Enrollment target: 455 to 650
    • Secondary endpoints: 4 to 11
    • Study description expanded, about 27 words
    • Eligibility criteria expanded, about 3 words
  3. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Sep 25, 2026 to Sep 2026
    • Study completion date: Dec 25, 2026 to Dec 2026
    • Start date changed from estimate of May 1, 2025 to Jun 1, 2025
    • Site details revised
  4. Start date: Mar 25, 2025 to May 1, 2025v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 this clinical trial is to evaluate whether the disclosure of Polygenic Risk Scores (PRS) combined with personalized coaching on risk factors can lead to significant improvements in lifestyle behaviors among staff members at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The study includes staff members from Fondazione Policlinico Universitario Agostino Gemelli IRCCS, enrolled at the outpatient clinics of the Cardiology Department. Main Research Questions: 1. Does receiving PRS disclosure and personalized coaching lead to significant improvements in lifestyle behaviors compared to baseline measurements? 2. How do different levels of genetic predisposition to cardiovascular diseases (CVD) impact behavioral changes following intervention? This is a single arm, pre-post clinical trial. Participant will: * Undergo genetic testing to assess their Polygenic Risk Score for CVDs * receive personalized, in-person consultation with a medical cardiologis, together with and individualized recommendations for CVD prevention based on PRS results and traditional risk factors.
Trial Details
NCT Number NCT06888466
Lead Sponsor Catholic University of the Sacred Heart
Conditions
(from sponsor)		 Cardiovascular Diseases
Related terms Cardiovascular Diseases, Genetic Risk Score
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov