Atlantic program to optimize cholesterol-lowering care
Official title: Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias
Run by Atlantic Health System · NCT06439654 · Data updated 2026-11-12
This program will try coordinated outreach with primary care providers to lower LDL-C in people with familial hypercholesterolemia or LDL-C ≥160 mg/dL.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Atlantic Health System Academic / other |
| Locations | 2 sites (Clark, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2024 |
| Main results expected | May 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | August 3, 2025 |
| Trial ID | NCT06439654 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with LDL-C ≥160 mg/dL, untreated LDL-C ≥190 with a family history of coronary artery disease, known familial hypercholesterolemia, or prior MI without optimized lipid therapy.
✕Probably not a fit
Patients who are pregnant, incarcerated, terminally ill, not willing to consent, or already at optimized lipid control are unlikely to benefit from this outreach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The program uses EHR screening to identify people with high LDL-C (≥160 mg/dL) or other markers of familial hypercholesterolemia and notifies their primary care providers. Study staff will send secure messages to the providers and, unless the provider opts out, reach out to patients to offer comprehensive lipid management services and education. Interventions are supportive care and coordination to optimize guideline-directed lipid-lowering therapy, follow-up testing, and referrals as needed. The primary goal is to see if this outreach and coordinated care can lower participants' LDL-C below baseline and ideally to ≤100 mg/dL.
Why it matters
Potential benefit: If successful, the program could help more people reach target LDL-C levels and lower their risk of heart attacks and other cardiovascular events.
How similar studies have gone: Other EHR-based outreach and care-coordination programs have produced modest but measurable improvements in statin use and LDL-C control, although FH-specific outreach models are less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * LDL-C ≥160 mg/dL * Untreated LDL-C ≥190 with family history of CAD * Prior MI and currently without optimized lipid-lowering therapy * Family history of CAD in first degree relative * Personal history of CAD * Untreated triglycerides \>500 * Elevated Lp(a) and/or high calcium scores * Consenting individuals Exclusion Criteria: * Individuals who are pregnant * Individuals who are incarcerated * Individuals with a terminal illness * Individuals who do not consent
Where it's running
-
Atlantic Medical Group
Springfield, New Jersey, United States Recruiting -
Atlantic Medical Group
Clark, New Jersey, United States Not yet recruiting
Study contacts
- Principal investigator: Robert D Fishberg, MD — Atlantic Health System
- Study coordinator: Robert D Fishberg, MD
- Email: robert.fishberg@atlantichealth.org
- Phone: 973-467-0005
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ORIGIN-FH: Newborn screening to detect familial high cholesterol
This project will test a genetic cheek swab of parents plus blood screening of newborns to find familial high cholesterol in babies born to parents with familial hypercholesterolemia.
-
Registry for hereditary cardiovascular diseases in Brazil
This study is trying to create a registry of Brazilian patients with hereditary heart diseases to see how common certain genetic changes are in people with these conditions.
-
Exploring YOLT-101 for treating Familial Hypercholesterolemia
This study is testing a new treatment called YOLT-101 to see if it can safely lower cholesterol levels in people with familial hypercholesterolemia.
-
Observational study on genetic lipid disorders in Italy
This study looks at families with high cholesterol to see how genetics affect their condition and treatment, using information gathered during regular doctor visits.
-
Improving detection of familial hypercholesterolemia through lab comments on cholesterol levels
This study is testing if adding helpful comments about high cholesterol levels in lab reports can lead to more people being referred for familial hypercholesterolemia diagnosis and treatment in Southern Denmark.
-
Comparing direct and indirect methods for screening family members at risk for genetic conditions
This study is testing two ways to reach out to family members at risk for Long QT Syndrome and Familial Hypercholesterolemia to see which method helps them get screened better, while also offering free genetic testing and counseling.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.