Atlantic Lipid Lowering Treatment Optimization Program

Familial Hypercholesterolemia Clinical Trial

— ALLTOP  

Official title:

Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06439654
• Other study ID #: 2096455
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Atlantic Health System
• Contact: Robert D Fishberg, MD
• Phone: 973-467-0005
• Email: robert.fishberg[@]atlantichealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: December 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• High Density Lipoprotein Deficiency
• Hypercholesterolemia
• Hyperlipidemias
• Hyperlipoproteinemia Type II
• Hyperlipoproteinemias
• Hypolipoproteinemias
• Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia

Intervention

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.

Locations

Country	Name	City	State
United States	Atlantic Medical Group	Clark	New Jersey
United States	Atlantic Medical Group	Springfield	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Atlantic Health System	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

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, Und — View 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 pati — View Citation

Khera AV, Won HH, Peloso GM, Lawson KS, Bartz TM, Deng X, van Leeuwen EM, Natarajan P, Emdin CA, Bick AG, Morrison AC, Brody JA, Gupta N, Nomura A, Kessler T, Duga S, Bis JC, van Duijn CM, Cupples LA, Psaty B, Rader DJ, Danesh J, Schunkert H, McPherson R, — View 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. — View 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. Erratum In: J Am Coll Cardiol. 2023 Jan 3;81(1):104. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with LDL-C maintenance<100	LDL-C <100 mg/dL after at least six months of therapy	6 months from enrollment in study
Secondary	Proportion of patients with LDL-C reaching <75	LDL-C <75 mg/DL	6 months from enrollment in study
Secondary	Proportion of patients with LDL-C reaching <55	LDL-C < 55mg/DL	6 months from enrollment in study