Actively Recruiting
The ORIGIN-FH Study
Led by University of Wisconsin, Madison · Updated on 2026-03-13
70
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The ORIGIN-FH Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 �3e=12 weeks gestation) where one or both partners have been diagnosed with possible or definite HoFH or HeFH based on Dutch Lipid Clinic Network or confirmed diagnosis from a healthcare provider.
- At least one parent with HoFH or HeFH must consent to participate; both parents are invited to participate.
- Parent(s) agree to use local laboratory services for infant blood samples; mobile phlebotomy allowed if available.
- Newborn does not have congenital abnormalities or medical conditions interfering with dried blood spot specimen collection.
- Newborn does not require admission to neonatal intensive care unit.
You will not qualify if you...
- Expectant partnership where neither partner meets diagnostic criteria for HeFH or HoFH.
- Parent refuses consent for newborn's study participation.
- Newborn has medical condition preventing dried blood spot specimen collection or specimen not collected by 1 week of age.
- Not suitable for study participation due to other reasons at the discretion of investigators.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
X
Xiao Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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