Cardiovascular DiseasesHEARTNCT05294419
The Healthcare Evaluation of Absolute Risk Testing Study
A study testing CVD Integrated Risk Test in people with Cardiovascular Diseases, run by Genomics PLC at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- CVD Integrated Risk Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 862 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Those excluded from NHS Health Checks;
- Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Carmel Medical Practice
Darlington, Co Durham, DL3 8SQ
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- CVD Integrated Risk Test
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVD Integrated Risk TestDevice
CVD IRT (Cardiovascular Integrated Risk Tool)
| Study group | Role | What they receive |
|---|---|---|
| Per participant - cardiovascular integrated risk score (CVD-IRT) | Other | The CVD IRT device will generate a result based on the polygenic risk score derived from participant genomic and phenotypic information Receives: Device: CVD Integrated Risk Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 1.3-8.9 months from baseline (study enrolment)
Secondary outcomes (7)
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%).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Within 6 months of study enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start4 Nov 2021
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genomics PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NHS North of England Commissioning Support (NECS)
- Responsible party
- Sponsor
- Investigators
- A Fuat, Prof, Principal investigator, Carmel Medical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294419
- Sponsor's protocol ID
- GEN2020-02
- Acronym
- HEART
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2021
- Last updated
- 8 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthcare Evaluation of Absolute Risk Testing Study: A Multi-centre, Single Arm, Pragmatic Study in Primary Care Setting
- ClinicalTrials.gov ID
- NCT05294419
- Acronym / sponsor ID
- HEART / GEN2020-02
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- Genomics PLCIndustry (pharma, biotech, devices)
- Collaborators
- NHS North of England Commissioning Support (NECS)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Posted 8 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Per participant - cardiovascular integrated risk score (CVD-IRT) | Other | Device: CVD Integrated Risk TestThe CVD IRT device will generate a result based on the polygenic risk score derived from participant genomic and phenotypic information |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Those excluded from NHS Health Checks;
- Currently prescribed and taking HMG-CoA reductase inhibitors (lipid-lowering preventive treatments or statins) for any indication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVD Integrated Risk TestCVD IRT (Cardiovascular Integrated Risk Tool) | Device | Per participant - cardiovascular integrated risk score (CVD-IRT) |
Primary outcome
Feasibility: Count of Participants Who Were Successfully Returned a Result
Time frame: 1.3-8.9 months from baseline (study enrolment)
Count of non-withdrawn participants (in "Participants Receiving CVD-IRT" arm) who were successfully returned a CVD-IRT result
HCP Perception: Count of HCPs Recommending Test (End-of-study Questionnaire)
Time frame: End of study (8-10 months after start of study)
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.
HCP Perception: Count of Favourable Ease-of-use Responses (Post-results Questionnaire)
Time frame: 1.3-8.9 months from baseline (study enrolment)
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)
Participant Satisfaction: Count of Participants Recommending Test in Post-results Questionnaire
Time frame: 1.3-10 months from baseline (study enrolment)
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
Participant Satisfaction: Count of Participants Who Found Test Useful in Post-results Questionnaire
Time frame: 1.3-10 months from baseline (study enrolment)
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
Participant Satisfaction: Count of Participants Who Found Test Easy to Understand in Post-results Questionnaire
Time frame: 1.3-10 months from baseline (study enrolment)
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
Feasibility: Result Return Time
Time frame: 1.3-8.9 months from baseline (study enrolment)
Time (in days) between study enrolment and receiving a CVD-IRT result (for participants in "Participants Receiving CVD-IRT" arm)
7 secondary outcomes
Risk Reclassification Counts
Time frame: 1.3-8.9 months from baseline (study enrolment)
CVD-IRT Mean Value
Time frame: 1.3-8.9 months from baseline (study enrolment)
HCP Impact: Count of Changed Management Decisions (Post-results Questionnaire)
Time frame: 1.3-8.9 months from baseline (study enrolment)
Participant Perception: Count of Participants Who Agreed Genetics is Important in Post-results Questionnaire
Time frame: 1.3-10 months from baseline (study enrolment)
Correlation in Saliva-derived and Blood-derived CVD-IRT Scores
Time frame: End of study (8-10 months after start of study)
Safety: Count of Participants Reporting Device Related Adverse Events or Deficiencies
Time frame: From start of study to end of study (10 months after start of study)
QRISK®2 Mean Value
Time frame: Within 6 months of study enrolment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A Fuat, Prof principal investigator
Carmel Medical Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVD Integrated Risk Test in people with Cardiovascular Diseases, run by Genomics PLC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Count of Participants Who Were Successfully Returned a Result (time frame: 1.3-8.9 months from baseline (study enrolment)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.