Familial HyperlipidemiaNCT05814419

Familial Hyperlipidemia Family Registry

An observational study of Familial Hyperlipidemia, run by Poudre Valley Health System at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

If a child from the Healthy Hearts and Minds education and screening program is found to have a genetic marker for familial hyperlipidemia (FH), immediate family members are offered genetic testing at no charge to identify those at high risk for cardiovascular disorders and those who carry the genetic markers. Read more about this study

Who is it for?: Ages 6 months to 60 years
Conditions the study is for: Familial Hyperlipidemia
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 17 Feb 2023to 29 May 2025
How long will I take part?: 4 Weeks
Phase: Observational
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 6 months to 60 years
All sexes
No healthy volunteers
Child, Adult

Study population: As above

Who may be able to join

Primary family member of child from school screening program with documented familial hyperlipidemia (FH) variant

Who cannot join

none

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical Center of the Rockies
Loveland, Colorado, 80528

Other trials in United States

About this study

The aim of the study is to gauge the impact of large-scale surveillance testing to identify those with the disorder and improve clinical care. This impact is both in disease prevention and in lessening the cost of long-term care from premature cardiovascular disease.

Conditions: Familial Hyperlipidemia
Keywords: Cholesterol, School based, Biometric Screening, Genetic, Healthy Hearts, Children

What is being measured

The primary outcome is the main question the study is designed to answer.

Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant
Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.
Measured: The duration of participation in study is one day.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 202329 May 2025

First posted14 Apr 2023
Study start17 Feb 2023
Primary completion29 May 2025
Study completion29 May 2025

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 Familial HyperlipidemiaStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 11 participants (actual)
Target duration: 4 Weeks

IDs, dates and publications

ClinicalTrials.gov ID: NCT05814419
Sponsor's protocol ID: 22-1979
Status last verified: Dec 2025
First submitted: 2 Mar 2023
Last updated: 19 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)

All Familial Hyperlipidemia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Familial Hyperlipidemia Family Registry
ClinicalTrials.gov ID: NCT05814419
Acronym / sponsor ID: 22-1979
Conditions: Familial Hyperlipidemia
Keywords: Cholesterol, School based, Biometric Screening, Genetic, Healthy Hearts, Children
Study type: Observational
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Poudre Valley Health SystemUniversity, hospital or other
Study start: 17 Feb 2023 (actual)
Primary completion: 29 May 2025 (actual)
Study completion: 29 May 2025 (actual)
First posted: 14 Apr 2023 (actual)
Results: Posted 19 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 4 Weeks

Who may qualify

Ages: 6 months to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: As above

Key inclusion criteria (1 listed)

Primary family member of child from school screening program with documented familial hyperlipidemia (FH) variant

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.

Primary outcome

Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant
Time frame: The duration of participation in study is one day.
Individuals with elevated cholesterol group with familial hypercholesterolemia genotype.

Results and safety

Results posted to the registry on 19 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Observational Registry Cohort	11	11

Primary outcome: Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant

Time frame: The duration of participation in study is one day.. Number. Unit: participants

Measure	Observational Registry Cohort n = 11
Positive	3
Negative	8

Population analysed: Individuals with elevated cholesterol group with familial hypercholesterolemia genotype. Not enough subjects participating to allow statistical analysis.

Adverse events

Time frame: There were no adverse events reported during the study from February 17, 2023 (time open to accrual) to May 29, 2025 (time closed to accrual). The only contact with participants was at enrollment so duration was 1 day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adverse Events	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Familial Hyperlipidemia

Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
Familial Hypercholesterolemia
Not yet recruitingObservational study
An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
Hypercholesterolaemia, Familial Hypercholesterolaemia
Active, not recruitingObservational study
Evaluation of the Effect of Lomitapide Treatment on Major Adverse Cardiovascular Events (MACE) in Patients With Homozygous Familial Hypercholesterolemia
Homozygous Familial Hypercholesterolemia (HoFH), Major Adverse Cardiovascular Events (MACE)
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Familial Hyperlipidemia, run by Poudre Valley Health System 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: finished, as of the sponsor's last update on 19 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?

Yes. Results are posted in the registry (first posted 19 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?

Familial Hypercholesterolemia (FH) Determination for Family Members of School Children With Elevated Cholesterol and Documented FH Variant (time frame: The duration of participation in study is one day.). 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 NCT05814419.

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 19 Dec 2025.