The Rogosin Institute Homozygous Familial Hypercholesterolemia Repository

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThe Rogosin Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Change in disease progression

Time frame
10 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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