| NCT ID | NCT07470723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Madison |
| Condition | Heterozygous Familial Hypercholesterolemia (HeFH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-02-14 |
| Primary Completion | 2029-02-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2026-02-14 with a primary completion date of 2029-02-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 that may interfere with collection of dried blood spot (DBS) specimen and newborn does not require admission to neonatal intensive care unit. Exclusion Criteria - parent and newborn participants: * Expectant partnership where neither partner meets diagnostic criteria for HeFH or HoFH. * Parent refuses consent for newborn's study participation. * Newborn has medical condition precluding DBS specimen collection, or a newborn's DBS specimen is not collected by 1 week of age. * Not suitable for study participation due to other reasons at the discretion of the investigators.
Contact & Investigator
Xiao Zhang, PhD
✉ xiao.zhang@wisc.eduAmy Peterson, MD, MS
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT07470723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heterozygous Familial Hypercholesterolemia (HeFH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07470723 currently recruiting?
Yes, NCT07470723 is actively recruiting participants. Contact the research team at xiao.zhang@wisc.edu for enrollment information.
Where is the NCT07470723 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT07470723 clinical trial?
NCT07470723 is sponsored by University of Wisconsin, Madison. The principal investigator is Amy Peterson, MD, MS at University of Wisconsin, Madison. The trial plans to enroll 70 participants.