The Healthcare Evaluation of Absolute Risk Testing Study (HEART)

The Healthcare Evaluation of Absolute Risk Testing Study: A Multi-centre, Single Arm, Pragmatic Study in Primary Care Setting

The aim of this study is to demonstrate the integration and use of cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures.

The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk.

This study is a device performance evaluation.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Device: CVD Integrated Risk Test

Detailed Description

The aim of this study is to demonstrate the integration and use of a cardiovascular disease (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

In association with the routine healthchecks for CVD, the QRISK score will be integrated with the individuals polygenic risk score (from a blood sample) to produce the CVD IRT score, this score estimates the risk of CVD in the following 10years.

This study will recruit participants of both biological sexes and any ancestry or background who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study, as they are more likely to be asymptomatic but also derive most benefit from preventative measures.

The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if incorporated into primary care practice for early identification of patients at highest risk.

This study is a device performance evaluation. 1000 participants are expected to be enrolled. Of this, it is expected that 200 surveys will be completed and from those surveyed 20-30 interviewed. This would be considered an adequate determination of feasibility.

• Study Type: Interventional
• Enrollment (Actual): 862
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Co Durham
    • Darlington, Co Durham, United Kingdom, DL3 8SQ
      • Carmel Medical Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Able and willing to provide written informed consent and to comply with the study protocol
• Either male or female (biological sex)
• Aged 45-64 years (inclusive)
• Any ancestry or background
• Eligible for NHS Health Check using QRISK®2 assessment

Exclusion Criteria:

• Those excluded from NHS Health Checks;
• Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Per participant - cardiovascular integrated risk score (CVD-IRT); The CVD IRT device will generate a result based on the polygenic risk score derived from participant genomic and phenotypic information	Device: CVD Integrated Risk Test; CVD IRT (Cardiovascular Integrated Risk Tool)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Count of Participants Who Were Successfully Returned a Result	Count of non-withdrawn participants (in "Participants Receiving CVD-IRT" arm) who were successfully returned a CVD-IRT result	1.3-8.9 months from baseline (study enrolment)
HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire)	Count of healthcare professionals responding "likely" or "very likely" in 5-point Likert response scale ("very unlikely" / "unlikely" / "undecided" / "likely" / "very likely") to the question "Would you recommend the test to colleagues in other practices?'" in HCP end-of-study questionnaire.	End of study (8-10 months after start of study)
HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire)	Count of "Yes" responses to the statement "The CVD-IRT can be incorporated into routine primary care in a straightforward manner" in the HCP post-results questionnaire (separate questionnaire filled at the time each CVD-IRT result was returned to participants)	1.3-8.9 months from baseline (study enrolment)
Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire	Count of participants responding "likely" or "very likely" in Likert 5-point response scale ("very unlikely" / "unlikely" / "undecided" / "likely" / "very likely") to the question "How likely would you be to recommend the use of this test to friends or family in similar situations?" in the questionnaire given to participants after receiving their CVD-IRT results	1.3-10 months from baseline (study enrolment)
Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire	Count of participants responding "Yes" to the question "Did you personally find this test useful?" in the questionnaire given to participants after receiving their CVD-IRT results	1.3-10 months from baseline (study enrolment)
Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire	Count of participants responding "Yes" to the question "Were the results easy to understand?" in the questionnaire given to participants after receiving their CVD-IRT results	1.3-10 months from baseline (study enrolment)
Feasibility: Result Return Time	Time (in days) between study enrolment and receiving a CVD-IRT result (for participants in "Participants Receiving CVD-IRT" arm)	1.3-8.9 months from baseline (study enrolment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk Reclassification Counts	Count of participants (in the "Participants Receiving CVD-IRT" arm) up-classified by the CVD-IRT (CVD-IRT≥10%, QRISK®2<10%) / down-classified by the CVD-IRT (CVD-IRT<10%, QRISK®2≥10%) / remained high risk (CVD-IRT≥10%, QRISK®2≥10%) / remained low risk (CVD-IRT<10%, QRISK®2<10%).	1.3-8.9 months from baseline (study enrolment)
CVD-IRT Mean Value	Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the CVD-IRT score	1.3-8.9 months from baseline (study enrolment)
HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire)	Count of "Yes" responses to the statement "If the participant's CVD IRT score was greater than the participant's QRISK2 score, did this influence your management decision?" in the HCP post-results questionnaire (separate questionnaire filled at the time each CVD-IRT result was returned to participants) - responses were only recorded if CVD-IRT> QRISK2	1.3-8.9 months from baseline (study enrolment)
Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire	Count of participants responding "agree" or "strongly agree" in Likert 5-point response scale ("strongly disagree" / "disagree" / "neither agree not disagree" / "agree" / "strongly agree") to the statement "When it comes to the risk of developing heart disease, genetics are as important to measure as factors such as blood pressure" in the questionnaire given to participants after receiving their CVD-IRT results	1.3-10 months from baseline (study enrolment)
Correlation in Saliva-derived and Blood-derived CVD-IRT Scores	Some participants donated a saliva sample in addition to the blood sample (the primary DNA collection method used in this study). At the end of the study, CVD-IRT scores were also calculated from the saliva samples, and these were correlated against the blood-derived CVD-IRT scores	End of study (8-10 months after start of study)
Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies	Safety: Count of participants reporting device related adverse events or deficiencies	From start of study to end of study (10 months after start of study)
QRISK®2 Mean Value	Mean risk score value (in the "Participants Receiving CVD-IRT" arm) of the QRISK®2 score	Within 6 months of study enrolment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usefulness of CVD IRT	HCP questionnaires based on a likert scale	HCP questionnaires within 2 months of last participant CVD-IRT reported
Usefulness of CVD IRT	HCP focus groups based on interview exploring themes in the questionnaires	HCP focus groups within 2 months of last participant CVD-IRT reported
Future development of genetic risk tests	PCC focus group based on interview exploring themes in the questionnaires	PCC focus groups within 2 months of last participant CVD-IRT reported

Collaborators and Investigators

• Sponsor: Genomics PLC
• Collaborators: NHS North of England Commissioning Support (NECS)
• Investigators: Principal Investigator: A Fuat, Prof, Carmel Medical Practice

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: GEN2020-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No