Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07470723

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Wisconsin - Madison

Madison, Wisconsin, United States, 53792

Actively Recruiting

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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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