Natural History of Uncommon Dyslipidemias, Rare Lipid Disorders and Unusual Atherosclerotic Conditions
Recruiting
Observational Study
DyslipidemiaAtherosclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
10 – 90
Sex
Any
Study type
Observational
Participants needed
1,500 (estimated)
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Who this trial is looking for
This trial is looking for individuals aged 10 and older with rare disorders affecting fat levels in the blood. Participants will have optional visits where their medical history will be reviewed, and they may undergo physical exams and blood tests.
Are You a Good Fit for This Trial?
You may be able to join if
I am 10 years old or older.
I have a confirmed or suspected rare lipid disorder.
I am willing to provide my medical history.
I can understand and sign a consent form.
You may not be able to join if
I have a common disorder affecting fat levels.
I have other conditions that my doctor believes would prevent me from joining.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Background:
The right amount of fats in the blood (cholesterol and triglycerides) are a key part of a healthy organism. Too much or too little of these fats may manifest as diseases (dyslipidemia). There are many causes for these abnormalities, but some are genetically determined and we would like to better understand the progression of these conditions over time.
Objective:
This natural histor…
Background:
The right amount of fats in the blood (cholesterol and triglycerides) are a key part of a healthy organism. Too much or too little of these fats may manifest as diseases (dyslipidemia). There are many causes for these abnormalities, but some are genetically determined and we would like to better understand the progression of these conditions over time.
Objective:
This natural history study aims to learn more about dyslipidemias; how they change over time; and how they respond to therapy. We also want to develop new diagnosis methods for these conditions. With the knowledge we will acquire we hope to provide new insights, new approaches and improve the overall health of these patients.
Eligibility:
Individuals aged 10 years and older, residing both within and outside the United States, who have or are suspected of having a disorder that causes changes in the levels of fats in their blood (genetic dyslipidemias).
Design:
Participants residing within and outside the United States will be screened. Their medical records may be reviewed. They may talk to researchers about their medical history by phone, telehealth, or in person.
All study visits are optional. Participants may visit the NIH up to 15 times per year, if needed.
Each visit may include a physical exam and blood tests. Participants may also have an electrocardiogram (EKG). The EKG measures the electrical activity when the heart beats.
In some cases, participants may remain in the study for up to 20 years.
Trial Locations
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Status
Eligibility Criteria
* INCLUSION CRITERIA:
Affected Participants
* Male and female participants age \>= 10 years.
* Subjects with confirmed or suspected rare disorder that causes lipid/lipoprotein abnormalities (dyslipidemia) or abnormal documented or referred atherosclerosis patterns.
* Only affected individuals (not…
* INCLUSION CRITERIA:
Affected Participants
* Male and female participants age \>= 10 years.
* Subjects with confirmed or suspected rare disorder that causes lipid/lipoprotein abnormalities (dyslipidemia) or abnormal documented or referred atherosclerosis patterns.
* Only affected individuals (not healthy volunteers and for self-referred subjects independent of lipid and lipoprotein marker values.); subjects with laboratory or clinical presentation that in the opinion of the Principal Investigator, would alter the determination of normal
parameters for assays and screening tools development.
-Ability of the subject or Legally Authorized Representative (LAR) to understand and willingness to sign a written informed consent document.
Healthy Volunteers
* Participants must be healthy, with no known history of lipid disorders or related medical conditions.
* Participants must not be pregnant.
EXCLUSION CRITERIA:
* Patients with disorders that cause common secondary/lipoprotein alterations.
* Patients with any other findings that, in the opinion of the Principal Investigator, would preclude them from participating in the study.
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