Understanding rare lipid disorders and their effects over time
Natural History of Uncommon Dyslipidemias, Rare Lipid Disorders and Unusual Atherosclerotic Conditions
National Institutes of Health Clinical Center (CC) · NCT06676046
This study is trying to understand how rare lipid disorders change over time and how they respond to treatments in people aged 10 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 10 Years to 90 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06676046 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the natural history of uncommon dyslipidemias and rare lipid disorders, focusing on how these conditions evolve and respond to therapies over time. Participants aged 10 years and older, both in the U.S. and internationally, will be enrolled to provide data on lipid levels and cardiovascular risk markers. The study will utilize both conventional and virtual methods to collect patient data and specimens, with the goal of developing new diagnostic tools and improving patient health outcomes.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 10 years and older with confirmed or suspected rare lipid disorders or abnormal atherosclerosis patterns.
Not a fit: Patients with common secondary disorders affecting lipid levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of rare lipid disorders, ultimately improving patient health.
How similar studies have performed: While there have been studies on common dyslipidemias, this focus on rare lipid disorders represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Marcelo J Amar, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Joy Lynne V Freeman
- Email: joylynne.freeman@nih.gov
- Phone: (301) 480-7632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dyslipidemia, Atherosclerosis, Uncommon Dyslipidemias, Rare Lipid Disorders, Unusual Atherosclerotic Conditions, Lipoproteins, TRIGLYCERIDES