An interventional study of Supportive care in Familial Hypercholesterolemia, Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia and Apolipoprotein B 100, Familial Defective, sponsored by Atlantic Health System. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by Atlantic Health System · Not applicable, Interventional, and Supportive care
Hypercholesterolemia is recognized as the major driver for cardiovascular morbidity and mortality. To help address this in our community, Atlantic Medical Group (AMG) formed a lipid workgroup chaired by Robert D. Fishberg, MD, and Jeffrey N. Feldman, MD. The overarching goal of the lipid workgroup is to enhance the treatment of lipid disorders in those patients with abnormal lipid levels by improving access to resources at the primary care practice level and specialty level. We aim to develop a model for primary and secondary prevention that integrates guidelines for treatment at the practice level. Our primary objective is to identify high-risk patients by utilizing the electronic health record and partnering with patients' primary care providers to provide comprehensive medical management.
This study will screen patients with LDL-C >160 mg/dL and with evidence of familial hypertension, reach out (using secure chat) to the attending practitioner of such patients and inform the practitioner of our comprehensive services to address FH. A study team member will inform the practitioner that one of the study team plans to reach out to their patient to inform the patient of the study. Unless one of the study team receives notification by the practitioner that they want to opt out of this service for their patients, and do not want further interaction, the patient will be informed of the study and the consent process.
The research question is: Will an innovative comprehensive outreach approach, in conjunction with the primary care provider, reduce LDL-C levels in individuals with familial hypercholesteremia below individual baseline values, ideally at a level at or below 100 mg/dL.
249 studies on the registry are indexed under Hyperlipoproteinemia Type II; 56 are open to participants now.
This study's planned enrollment of 250 is above the median of 134 across 178 interventional studies indexed under Hyperlipoproteinemia Type II.
Browse Hyperlipoproteinemia Type II studies →Atlantic Health System is the lead sponsor of 64 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Most recent LDL-C result
Other: Supportive care
The study model will utilize the accepted standard of care while implementing key enhancements to proactively reach high-risk patients as early as possible. Wrap around comprehensive care is defined as database screening, outreach, encouraging genetic testing for participants and their family members, and provide ongoing education, medical management (e.g., adherence to FDA-approved medications), routine laboratory testing, specialist referrals, Epic referrals to integrated care support such as pharmacy, nutrition, social work, and community health), and routine follow-up either in-person or using virtual visits. Consultations with pharmacists, nutritionists and genetic counselors or specialists to manage co-morbidities may be requested.
Proportion of patients with LDL-C maintenance<100
LDL-C \<100 mg/dL after at least six months of therapy
Time frame: 6 months from enrollment in study
Proportion of patients with LDL-C reaching <75
LDL-C \<75 mg/DL
Time frame: 6 months from enrollment in study
Proportion of patients with LDL-C reaching <55
LDL-C \< 55mg/DL
Time frame: 6 months from enrollment in study
Plan to share: No — De-identified data will be disseminated in aggregate.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Hyperlipoproteinemia Type II →
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