Evidence map›Paper›PMID 41941500›Full record

Trial reportPloS one2026

Polygenic Risk Scores disclosure for cardiovascular prevention: Protocol of the Personalized HeartCare (PHC) trial.

Luigi Russo, Luca Proto, Sara Farina, Eleonora Pascucci, Riccardo Galarducci, Tina Pasciuto, Anna Severino, Giovanna Liuzzo, Andrea Urbani, Ivo Iavicoli and 2 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06888466 (Personalised HeartCare), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06888466 narecruitingnot on this map

Personalised HeartCare: Poligenic Risk Scores Disclosure for Cardiovascular Prevention and Behavioral Change

TypeinterventionalSponsorCatholic University of the Sacred HeartRan2025 to 2026Enrolled650ConditionsCardiovascular DiseasesArmsThe result of the Polygenic Risk Score will be communicated to the patient with the aim of encouraging a change in behavior
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Luigi RussoSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.
Luca ProtoSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.
Sara FarinaSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0000-0002-9853-5278
Eleonora PascucciSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.
Riccardo GalarducciSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.
Tina PasciutoSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0000-0003-2959-8571
Anna SeverinoDepartment of Cardiovascular and Pulmonary Sciences, Università Cattolica School of Medicine, Rome, Italy.
Giovanna LiuzzoDepartment of Cardiovascular and Pulmonary Sciences, Università Cattolica School of Medicine, Rome, Italy.
Andrea UrbaniDepartment of Diagnostic and Laboratory Medicine, Unity of Chemistry, Biochemistry and Clinical Molecular Biology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Ivo IavicoliSection of Occupational Medicine, Department of Healthcare Surveillance and Bioethics, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Roberta PastorinoSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.ORCID https://orcid.org/0000-0001-5013-0733
Stefania BocciaSection of Hygiene, Department of Life Sciences and Public Health, Università Cattolica del Sacro Cuore, Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiovascular diseases (CVDs) are the leading cause of death and morbidity in Europe, highlighting the need for innovative and personalized prevention strategies. Communicating genetic risk through Polygenic Risk Scores (PRSs) may help promote healthier behaviors, though evidence remains limited. This trial aims to assess whether PRS disclosure can support lifestyle changes and its implementation into clinical practice.

methodsThe PHC study is a single-arm clinical trial whose primary objective is to assess the effectiveness of communicating CVD PRSs in modifying the lifestyle behaviors, based on the Life's Essential 8 (LE8) questionnaire. Secondary endpoints include changes in SCORE2 and LDL-cholesterol levels. Additionally, the study aims to evaluate the feasibility and acceptability of the intervention for participants and physicians, and the working ability through the Work Ability Index. The trial enrolls 650 healthy participants from the general population, aged over 40 years, who must have a 10-year CVD risk of less than 10% on the SCORE2 charts or less than 15% on the SCORE2-OP. All participants undergo an initial assessment at baseline (T0), a disclosure visit one month later (T1) to receive the PRS and lifestyle results, and health recommendations, and a final follow-up at six months (T2) for the reassessment of lifestyle behaviors and modifications. DISCUSSION: This study explores the innovative use of PRS to enhance primary prevention of cardiovascular diseases, potentially improving individual risk stratification beyond traditional clinical models. By combining PRS with conventional factors, it aims to test whether disclosure can motivate lifestyle improvements. Furthermore, it explores the practical integration of PRS communication into routine care, assessing both participant acceptance and clinician workflow impact, offering insights into real-world implementation of PRS. The findings may inform how PRS can be integrated into clinical workflows, contributing to advance personalized prevention strategies, and help implement PRS-based interventions in health systems. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06888466.

Indexed as

Cardiovascular DiseasesPrecision MedicineAdultFemaleGenetic Risk ScoreHumansLife StyleMaleMiddle AgedReturn of Individual Research ResultsSurveys and Questionnaires

Identifiers

PMID41941500
PMCPMC13052841

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.