Familial HypercholesterolemiaCARE-FHNCT05284513
Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
A study testing FH diagnosis program, Implementation strategy package: Develop and implement tools for quality monitoring and Implementation strategy package: Develop educational materials in people with Familial Hypercholesterolemia, run by Geisinger Clinic at 1 site in United States.
Trial summary
Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Read more about this study
- Who is it for?
- Ages 26 years and older
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- FH diagnosis program, Implementation strategy package: Develop and implement tools for quality monitoring and Implementation strategy package: Develop educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 532 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 26 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Geisinger Clinic
Multiple Locations, Pennsylvania, 00000
About this study
Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Using a stepped-wedge design, the investigators plan to utilize tools from implementation science to improve uptake, acceptability, and sustainability of FH diagnostic programs in primary care settings. If successful, this study will provide tools generalizable to other health care systems to improve FH diagnosis rates.
Read the detailed description
Familial hypercholesterolemia (FH) is a common genetic disorder (prevalence 1 in 250) that requires lifelong sustained medical care. Evidence-based guidelines for screening and treatment for FH exist. These include universal screening of children ages 9-11, of adolescents ages 18-20, and of adults ages 40 and above; approved diagnostic tools including lipid panels and genetic testing; and recommendations for initiation of lipid lowering medication. FH diagnosis is currently made too late in life, often after a premature heart attack has occurred creating a care gap that results in excess cardiovascular morbidity and mortality. Diagnosing FH in the primary care setting would optimize treatment for individuals with FH and close this care gap. Utilizing tools from implementation science and human centered design, and by considering uptake, acceptability, and sustainability of programs related to FH care should improve earlier diagnosis. Implementation strategies that include insights from patients, clinicians, and healthcare systems are necessary. The long-term goal is to create an effective FH diagnosis program that is practical and sustainable in the real-world setting. The main objective of this project is to determine the uptake of an FH diagnosis program integrated into primary care practices to promote early identification of adult and pediatric patients that is generalizable to other healthcare settings. The research question is, does using a multi-level implementation strategy package, designed to address the specific needs of patients, clinicians, and healthcare systems, improve the diagnosis and activation of care management for individuals with FH. The specific aims are to: 1) to design a clinical trial to assess multi-level implementation strategies for improving FH diagnosis in an integrated health system, 2) compare FH diagnosis rates among primary care clinicians who receive the implementation strategy package versus those who do not, 3) to measure implementation success of an organized FH diagnosis program, and 4) to explore patient-related service and health outcomes related to an FH diagnosis program.
- Conditions
- Familial Hypercholesterolemia
- Being tested
- FH diagnosis program, Implementation strategy package: Develop and implement tools for quality monitoring, Implementation strategy package: Develop educational materials, Implementation strategy package: Conduct educational outreach visits, Implementation strategy package: Intervene with clinicians and patients to enhance
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FH diagnosis programBehavioural
Uptake of screening, diagnosis, and initiation of care management for FH
Implementation strategy package: Develop and implement tools for quality monitoringBehavioural
EHR tools to order labs, record results, and document FH care
Implementation strategy package: Develop educational materialsBehavioural
Education regarding guidelines for identification and treatment of FH
Implementation strategy package: Conduct educational outreach visitsBehavioural
Continuing medical education (CME) material for FH that is presented to
Implementation strategy package: Intervene with clinicians and patients to enhanceBehavioural
Notify patients simultaneously with clinicians about the need for screening
Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid championsBehavioural
Clinical lipid champions
Implementation strategy package: Audit and provide feedbackBehavioural
Provide aggregate level feedback to clinics on diagnosing FH
Implementation strategy package: Stage implementation scale upBehavioural
Develop the timeline for the stepped-wedge rollout to primary care
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Other | Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Receives: Behavioral: FH diagnosis program; Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring; Behavioral: Implementation strategy package: Develop educational materials; Behavioral: Implementation strategy package: Conduct educational outreach visits; Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance; Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions; Behavioral: Implementation strategy package: Audit and provide feedback; Behavioral: Implementation strategy package: Stage implementation scale up |
| Phase 2 | Other | Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Receives: Behavioral: FH diagnosis program; Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring; Behavioral: Implementation strategy package: Develop educational materials; Behavioral: Implementation strategy package: Conduct educational outreach visits; Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance; Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions; Behavioral: Implementation strategy package: Audit and provide feedback; Behavioral: Implementation strategy package: Stage implementation scale up |
| Phase 3 | Other | Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Receives: Behavioral: FH diagnosis program; Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring; Behavioral: Implementation strategy package: Develop educational materials; Behavioral: Implementation strategy package: Conduct educational outreach visits; Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance; Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions; Behavioral: Implementation strategy package: Audit and provide feedback; Behavioral: Implementation strategy package: Stage implementation scale up |
| Phase 4 | Other | Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Receives: Behavioral: FH diagnosis program; Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring; Behavioral: Implementation strategy package: Develop educational materials; Behavioral: Implementation strategy package: Conduct educational outreach visits; Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance; Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions; Behavioral: Implementation strategy package: Audit and provide feedback; Behavioral: Implementation strategy package: Stage implementation scale up |
| Phase 5 | Other | Phased rollout to clinic sites across the the Geisinger system using stepped wedge design Receives: Behavioral: FH diagnosis program; Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring; Behavioral: Implementation strategy package: Develop educational materials; Behavioral: Implementation strategy package: Conduct educational outreach visits; Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance; Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions; Behavioral: Implementation strategy package: Audit and provide feedback; Behavioral: Implementation strategy package: Stage implementation scale up |
What is being measured
The primary outcome is the main question the study is designed to answer.
FH diagnosis rate (Aim 2)
FH diagnosis rate, is achieving both the scheduling of a clinic visit and evidence the clinician, at that visit, has completed evidence-based FH diagnostic evaluation, defined as completing one of: using the FH clinic note to document care, adding FH diagnosis on the problem list, using the FH smart-set (or ordered a genetic test for FH), making a referral to the lipid clinic, or starting a statin for an evidence-based indication
Measured: Up to 45 months
Acceptability (Aim 3)
Clinician and patient satisfaction and self-efficacy with the FH diagnosis program
Measured: Month 9, 12, 18, 24, 30, 36, 42
Timeliness (Aim 4)
Time to FH screen, time to diagnostic evaluation, time to statin initiation
Measured: Up to 45 months
Secondary outcomes (12)
Initiation medication use (Aim 2)
Initiation of lipid lowering medication by healthcare clinician
Measured: Up to 45 months
Lipid measurement (Aim 2)
Order of a lipid panel
Measured: Up to 45 months
Genetic testing (Aim 2)
Order of a genetic test for FH
Measured: Month 9, 12, 18, 24, 30, 36, 42
Problem list diagnosis of FH (Aim 2)
Clinician adds diagnosis of FH to the patients problem list in the electronic health record
Measured: Up to 45 months
FH smartset (Aim 2)
Clinician uses and completes all field of the FH smartset
Measured: Month 9, 12, 18, 24, 30, 36, 42
Best Practice Alert (Aim 2)
Clinician adheres to and acts on recommendation in the Best Practice Alert
Measured: Up to 45 months
FH Clinic Note (Aim 2)
Clinician completes the FH clinic note
Measured: Up to 45 months
Fidelity (Aim 3)
Documentation of adaptations to the FH diagnosis program
Measured: Up to 45 months
Cost (Aim 3)
Cost to implement the implementation strategy package
Measured: Up to 45 months
Function (Aim 4)
Return of genetic result to patient (if ordered and patient undergoes testing)
Measured: Up to 45 months
Function (Aim 4)
Reduction in lipid level from baseline to end of the study period
Measured: Up to 45 months
Function (Aim 4)
Patient side effects to medications
Measured: Up to 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start9 Sep 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge design
- Masking
- None (open label)
- Enrolment
- 532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Samuel Gidding, Geisinger Clinic
- Investigators
- Laney K Jones, PharmD, MPH, Principal investigator, Geisinger ClinicSamuel S Gidding, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284513
- Sponsor's protocol ID
- 2021-0927
- Other IDs
- 1R61HL161775
- Acronym
- CARE-FH
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available upon request from PIs
Publications
Jones LK, Romagnoli KM, Schubert TJ, Clegg K, Kirchner HL, Hu Y, Cawley D, Norelli V, Williams MS, Gidding SS, Rahm AK. Using implementation science to develop a familial hypercholesterolemia screening program in primary care: The CARE-FH study. J Clin Lipidol. 2024 Mar-Apr;18(2):e176-e188. doi: 10.1016/j.jacl.2024.01.001. Epub 2024 Jan 4.
PubMed 38228467
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Approach to Reach Everyone With Familial Hypercholesterolemia (CARE-FH)
- ClinicalTrials.gov ID
- NCT05284513
- Acronym / sponsor ID
- CARE-FH / 2021-0927
- Conditions
- Familial Hypercholesterolemia
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 532 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diagnosis rates of familial hypercholesterolemia (FH) are low in the United States, despite multiple guidelines and recommendations for screening and treatment of high cholesterol, to prevent heart attacks in those affected. Using a stepped-wedge design, the investigators plan to utilize tools from implementation science to improve uptake, acceptability, and sustainability of FH diagnostic programs in primary care settings. If successful, this study will provide tools generalizable to other health care systems to improve FH diagnosis rates.
Detailed description
Familial hypercholesterolemia (FH) is a common genetic disorder (prevalence 1 in 250) that requires lifelong sustained medical care. Evidence-based guidelines for screening and treatment for FH exist. These include universal screening of children ages 9-11, of adolescents ages 18-20, and of adults ages 40 and above; approved diagnostic tools including lipid panels and genetic testing; and recommendations for initiation of lipid lowering medication. FH diagnosis is currently made too late in life, often after a premature heart attack has occurred creating a care gap that results in excess cardiovascular morbidity and mortality. Diagnosing FH in the primary care setting would optimize treatment for individuals with FH and close this care gap. Utilizing tools from implementation science and human centered design, and by considering uptake, acceptability, and sustainability of programs related to FH care should improve earlier diagnosis. Implementation strategies that include insights from patients, clinicians, and healthcare systems are necessary. The long-term goal is to create an effective FH diagnosis program that is practical and sustainable in the real-world setting. The main objective of this project is to determine the uptake of an FH diagnosis program integrated into primary care practices to promote early identification of adult and pediatric patients that is generalizable to other healthcare settings. The research question is, does using a multi-level implementation strategy package, designed to address the specific needs of patients, clinicians, and healthcare systems, improve the diagnosis and activation of care management for individuals with FH. The specific aims are to: 1) to design a clinical trial to assess multi-level implementation strategies for improving FH diagnosis in an integrated health system, 2) compare FH diagnosis rates among primary care clinicians who receive the implementation strategy package versus those who do not, 3) to measure implementation success of an organized FH diagnosis program, and 4) to explore patient-related service and health outcomes related to an FH diagnosis program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Stepped-wedge design
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Other | Behavioral: FH diagnosis program, Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring, Behavioral: Implementation strategy package: Develop educational materials, Behavioral: Implementation strategy package: Conduct educational outreach visits, Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance, Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions, Behavioral: Implementation strategy package: Audit and provide feedback, Behavioral: Implementation strategy package: Stage implementation scale upPhased rollout to clinic sites across the the Geisinger system using stepped wedge design |
| Phase 2 | Other | Behavioral: FH diagnosis program, Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring, Behavioral: Implementation strategy package: Develop educational materials, Behavioral: Implementation strategy package: Conduct educational outreach visits, Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance, Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions, Behavioral: Implementation strategy package: Audit and provide feedback, Behavioral: Implementation strategy package: Stage implementation scale upPhased rollout to clinic sites across the the Geisinger system using stepped wedge design |
| Phase 3 | Other | Behavioral: FH diagnosis program, Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring, Behavioral: Implementation strategy package: Develop educational materials, Behavioral: Implementation strategy package: Conduct educational outreach visits, Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance, Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions, Behavioral: Implementation strategy package: Audit and provide feedback, Behavioral: Implementation strategy package: Stage implementation scale upPhased rollout to clinic sites across the the Geisinger system using stepped wedge design |
| Phase 4 | Other | Behavioral: FH diagnosis program, Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring, Behavioral: Implementation strategy package: Develop educational materials, Behavioral: Implementation strategy package: Conduct educational outreach visits, Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance, Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions, Behavioral: Implementation strategy package: Audit and provide feedback, Behavioral: Implementation strategy package: Stage implementation scale upPhased rollout to clinic sites across the the Geisinger system using stepped wedge design |
| Phase 5 | Other | Behavioral: FH diagnosis program, Behavioral: Implementation strategy package: Develop and implement tools for quality monitoring, Behavioral: Implementation strategy package: Develop educational materials, Behavioral: Implementation strategy package: Conduct educational outreach visits, Behavioral: Implementation strategy package: Intervene with clinicians and patients to enhance, Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid champions, Behavioral: Implementation strategy package: Audit and provide feedback, Behavioral: Implementation strategy package: Stage implementation scale upPhased rollout to clinic sites across the the Geisinger system using stepped wedge design |
Who may qualify
- Ages
- 26 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care clinicians (pediatrician, community medicine, internal medicine) in the Geisinger Healthcare System
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| FH diagnosis programUptake of screening, diagnosis, and initiation of care management for FH | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
| Implementation strategy package: Develop and implement tools for quality monitoringEHR tools to order labs, record results, and document FH care | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
| Implementation strategy package: Develop educational materialsEducation regarding guidelines for identification and treatment of FH | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
| Implementation strategy package: Conduct educational outreach visitsContinuing medical education (CME) material for FH that is presented to | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
| Implementation strategy package: Intervene with clinicians and patients to enhanceNotify patients simultaneously with clinicians about the need for screening | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
| Behavioral (e.g., Psychotherapy, Lifestyle Counseling) Implementation strategy package: Identify and prepare champions Clinical lipid championsClinical lipid champions | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
| Implementation strategy package: Audit and provide feedbackProvide aggregate level feedback to clinics on diagnosing FH | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
| Implementation strategy package: Stage implementation scale upDevelop the timeline for the stepped-wedge rollout to primary care | Behavioural | Phase 1, Phase 2, Phase 3, Phase 4, Phase 5 |
Primary outcome
FH diagnosis rate (Aim 2)
Time frame: Up to 45 months
FH diagnosis rate, is achieving both the scheduling of a clinic visit and evidence the clinician, at that visit, has completed evidence-based FH diagnostic evaluation, defined as completing one of: using the FH clinic note to document care, adding FH diagnosis on the problem list, using the FH smart-set (or ordered a genetic test for FH), making a referral to the lipid clinic, or starting a statin for an evidence-based indication
Acceptability (Aim 3)
Time frame: Month 9, 12, 18, 24, 30, 36, 42
Clinician and patient satisfaction and self-efficacy with the FH diagnosis program
Timeliness (Aim 4)
Time frame: Up to 45 months
Time to FH screen, time to diagnostic evaluation, time to statin initiation
12 secondary outcomes
Initiation medication use (Aim 2)
Time frame: Up to 45 months
Lipid measurement (Aim 2)
Time frame: Up to 45 months
Genetic testing (Aim 2)
Time frame: Month 9, 12, 18, 24, 30, 36, 42
Problem list diagnosis of FH (Aim 2)
Time frame: Up to 45 months
FH smartset (Aim 2)
Time frame: Month 9, 12, 18, 24, 30, 36, 42
Best Practice Alert (Aim 2)
Time frame: Up to 45 months
FH Clinic Note (Aim 2)
Time frame: Up to 45 months
Fidelity (Aim 3)
Time frame: Up to 45 months
Cost (Aim 3)
Time frame: Up to 45 months
Function (Aim 4)
Time frame: Up to 45 months
Function (Aim 4)
Time frame: Up to 45 months
Function (Aim 4)
Time frame: Up to 45 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 38228467Jones LK, Romagnoli KM, Schubert TJ, Clegg K, Kirchner HL, Hu Y, Cawley D, Norelli V, Williams MS, Gidding SS, Rahm AK. Using implementation science to develop a familial hypercholesterolemia screening program in primary care: The CARE-FH study. J Clin Lipidol. 2024 Mar-Apr;18(2):e176-e188. doi: 10.1016/j.jacl.2024.01.001. Epub 2024 Jan 4.
- Individual participant dataSharing planned: No. Available upon request from PIs
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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.
Laney K Jones, PharmD, MPH principal investigator
Geisinger Clinic
Samuel S Gidding, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FH diagnosis program, Implementation strategy package: Develop and implement tools for quality monitoring and Implementation strategy package: Develop educational materials in people with Familial Hypercholesterolemia, run by Geisinger Clinic at 1 site in United States.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 22 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 States. 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?
This study is still under way. Results are not available in the source record yet.
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?
FH diagnosis rate (Aim 2) (time frame: Up to 45 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05284513, which also lists 1 linked publication.
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 22 Dec 2025.