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Recruiting NCT07470723

The ORIGIN-FH Study

Trial Parameters

Condition Heterozygous Familial Hypercholesterolemia (HeFH)
Sponsor University of Wisconsin, Madison
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-02-14
Completion 2029-02-14
Interventions
Screening for FH

Brief Summary

The goal of this clinical trial is to identify different types of Familial Hypercholesterolemia (FH) in infants and newborns. Participants will: * undergo a cheek swab for genetic testing (parents only) * have 5 blood samples collected Participants can expect to be in the trial for 2 years.

Eligibility Criteria

Inclusion Criteria - parent participant: * Individuals in the expectant partnership providing informed consent are at least 18 years of age. * Ability to understand and willingness to sign a written informed consent document. * Willingness to comply with all study procedures and be available for the duration of the study. * Expectant parent (currently pregnant with fetus ≥12 weeks gestation) where one or both partners have been diagnosed with possible or definite HoFH or HeFH based on Dutch Lipid Clinic Network (DLCN) or confirmed diagnosis from a healthcare provider. At minimum, at least one parent with HoFH or HeFH must be willing to consent to study participation. However, both parents will be invited to participate. * Parent(s) commit to using local laboratory services for infant blood samples, with mobile phlebotomy used as an alternative if available in their area. Inclusion Criteria - newborn participant: * Newborn does not have any congenital abnormalities or medical conditions

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