About this trial
This repository will establish for the first time a system to carefully assess and monitor over time the general health and the amount of cholesterol in the arteries of U.S. children and adults with homozygous familial hypercholesterolemia (hoFH). Patients with this very rare disorder have very high blood levels of cholesterol from birth due to the inheritance of an abnormal gene from each parent. As a result, if untreated, heart attacks and sudden death occur in childhood. Treatments such as LDL-apheresis and liver transplant will lower the cholesterol level, but the best treatment and the best way to monitor the effect of the treatment on the arteries are unknown. The collection of clinical data and blood for analysis of known and yet-to-be discovered markers and predictors of arterial disease will yield new information about the natural history of the disorder and response to treatment. The repository will greatly aid the development of specific protocols that seek to learn more about this disease and new therapies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
DNA confirmation of a double mutation of the LDL receptor or apoB gene OR
LDL > 160 mg/dL in both biological parents not associated with a disorder know to elevate LDL OR
Coronary artery disease in one or both parents or grandparents < 55 years for males, < 65 for females OR
Tendinous/cutaneous xanthomas < age 10 or coronary artery disease < age 20
Disqualifiers
None
Trial population
Males and females of any age with severely elevated LDL cholesterol levels without secondary causes and a family history consistent with an autosomal dominant disorder.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in disease progression
Sponsors and contacts
Click on the lead sponsor to view all of their trials.