New study aims to get more heart patients tested for hidden genetic risk
NCT ID NCT07508007
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether special strategies can help doctors test more patients for Lp(a), a genetic risk factor for heart disease. Researchers will compare testing rates before and after these strategies are used in clinics. The goal is to see if simple changes can help follow medical guidelines and catch more at-risk patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to more people being tested for Lp(a), helping doctors identify and manage heart disease risk earlier.
- What could go wrong
- This is an implementation study, not a treatment trial. It tests whether strategies boost testing rates, not whether testing improves health outcomes. Results may vary by clinic.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 4,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
cardiology centers (or equivalent) with low or inconsistent Lp(a) testing in Germany, Italy and the UK
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Each cluster within this study has a set of inclusion criteria. In addition, to be eligible for inclusion in this study, all the following criteria at the cluster-level must be met: Inclusion criteria for centers: 1. Lp(a) testing is available in this center and reimbursed. 2. Capacity to increase Lp(a) testing in relevant patient groups (according to the defined patient eligibility criteria). 3. Low and/or inconsistent Lp(a) testing rate(number of eligible patients tested for Lp(a)/number of eligible patients seen) \<15%. 4. Willingness to fulfill research requirements, e.g., repurposing existing clinic data for research etc. 5. Seeing a defined number of eligible patients per year based on the sample size required for the study. 6. Availability of local infrastructure and data interoperability. Inclusion criteria for HCP survey participants: 1\. CV specialists or other HCPs managing and accessing CV risk at their respective centers (cardiology units or equivalent). Electronic records are eligible for assessment in this study if they meet all the following criteria: 1. ICF and/or ICF waiver will be sought prior to abstraction of electronic patient records. 2. Patients attending at least one SOC visit during the pre-defined time intervals (12 months prior to index date and 0-6 months, 7-12 months and 13-24 months post-index). 3. Previous Lp(a) testing: 1. Patients with an Lp(a) test recorded before the index date will be included in the baseline assessment, which covers the 12 months prior to the index date. 2. For post-index assessments at 6-, 12- and 24-months after the index date, patients with an Lp(a) test recorded before the index date will be excluded. 4. Over 18 years of age and qualify for Lp(a) testing according to local practice. Exclusion Criteria: Exclusion criteria at center cluster-level includes: 1. Centers with no access to Lp(a) testing. 2. Centers where Lp(a) testing is not reimbursed. Electronic records will not be assessed for: 1\. Patients that have undergone Lp(a) testing prior to index date (for the post-index assessment)
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Novartis Investigative Site
RECRUITINGNuremberg, 90443, Germany