70 Participants NeededMy employer runs this trial

Screening for High Cholesterol

(ORIGIN-FH Trial)

XZ
Overseen ByXiao Zhang, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AP

Amy Peterson, MD, MS

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for expectant parents (at least one with diagnosed familial hypercholesterolemia) who are at least 18 years old, willing to provide consent and blood samples, and whose newborn does not have serious medical conditions or need intensive care.

Inclusion Criteria

Parent(s) commit to using local laboratory services for infant blood samples, with mobile phlebotomy used as an alternative if available in their area
I am at least 12 weeks pregnant and one or both parents have been diagnosed with HoFH or HeFH.
Ability to understand and willingness to sign a written informed consent document
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Exclusion Criteria

Parent refuses consent for newborn's study participation
Expectant partnership where neither partner meets diagnostic criteria for HeFH or HoFH
Newborn has medical condition precluding DBS specimen collection, or a newborn's DBS specimen is not collected by 1 week of age
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Testing

Parents undergo a cheek swab for genetic testing and newborns are screened for FH

1 month
1 visit (in-person)

Monitoring

Participants have 5 blood samples collected over the course of the study

2 years

Follow-up

Participants are monitored for differences in lipid profiles over time

2 years

What Are the Treatments Tested in This Trial?

Trial Overview

The study screens infants for different types of familial hypercholesterolemia using genetic testing from a cheek swab (parents) and five blood samples over two years. It aims to identify FH early in life.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: NewbornsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+