Clinical trial NCT06439654: Atlantic Lipid Lowering Treatment Optimization Program
Official title: Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Familial Hypercholesterolemia
Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia
Apolipoprotein B 100, Familial Defective
High Density Lipoprotein Deficiency
Low-Density-Lipoid-Type Hyperlipoproteinemia
Keywords: treatment optimization; familial hypercholesterolemia; complex dyslipidemia
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2024-06-03
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective quantitative study of individuals with FH to examine the benefit of comprehensive supportive care to lower elevated LDL-C and sustain healthy levels through 36 months from baseline enrollment. We propose to demonstrate improvement in lipid parameters and outcomes in patients referred to the study. Specifically, we will target patients with documented hypercholesterolemia, hypertriglyceridemia, prior myocardial infarction, and personal or family history of coronary artery disease, who may be living with undiagnosed/untreated familial hypercholesterolemia FH.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Proportion of patients with LDL-C maintenance<100
timeFrame: 6 months from enrollment in study
Secondary outcomes:
measure: Proportion of patients with LDL-C reaching <75
timeFrame: 6 months from enrollment in study
measure: Proportion of patients with LDL-C reaching <55
timeFrame: 6 months from enrollment in study
Other outcomes:
Locations:
city: Clark
country: United States
facility: Atlantic Medical Group
state: New Jersey
city: Springfield
country: United States
facility: Atlantic Medical Group
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Robert D Fishberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Writing Committee; Lloyd-Jones DM, Morris PB, Ballantyne CM, Birtcher KK, Covington AM, DePalma SM, Minissian MB, Orringer CE, Smith SC Jr, Waring AA, Wilkins JT. 2022 ACC Expert Consensus Decision Pathway on the Role of Nonstatin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 Oct 4;80(14):1366-1418. doi: 10.1016/j.jacc.2022.07.006. Epub 2022 Aug 25. No abstract available.
citation: Myers KD, Farboodi N, Mwamburi M, Howard W, Staszak D, Gidding S, Baum SJ, Wilemon K, Rader DJ. Effect of Access to Prescribed PCSK9 Inhibitors on Cardiovascular Outcomes. Circ Cardiovasc Qual Outcomes. 2019 Aug;12(8):e005404. doi: 10.1161/CIRCOUTCOMES.118.005404. Epub 2019 Jul 23.
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citation: Amrock SM, Duell PB, Knickelbine T, Martin SS, O'Brien EC, Watson KE, Mitri J, Kindt I, Shrader P, Baum SJ, Hemphill LC, Ahmed CD, Andersen RL, Kullo IJ, McCann D, Larry JA, Murray MF, Fishberg R, Guyton JR, Wilemon K, Roe MT, Rader DJ, Ballantyne CM, Underberg JA, Thompson P, Duffy D, Linton MF, Shapiro MD, Moriarty PM, Knowles JW, Ahmad ZS. Health disparities among adult patients with a phenotypic diagnosis of familial hypercholesterolemia in the CASCADE-FH patient registry. Atherosclerosis. 2017 Dec;267:19-26. doi: 10.1016/j.atherosclerosis.2017.10.006. Epub 2017 Oct 6.
citation: Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.
citation: Alam L, Fishberg R, Echeverry T, Feldman J. Screening for familial hypercholesterolemia using Epic Secure Chat in comparison to Epic Letter as educational outreach. Journal of Clinical Lipidology. 2022;16(1):e20-e21. doi.org/10.1016/j.jacl.2021.09.029