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NCT Number: NCT06439654

Atlantic Lipid Lowering Treatment Optimization Program

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.

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Key information

Conditions

Familial Hypercholesterolemia Apolipoprotein B 100, Familial Defective Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Genetic Diseases, Inborn High Density Lipoprotein Deficiency Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Hypoalphalipoproteinemias Hypolipoproteinemias LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Low-Density-Lipoid-Type Hyperlipoproteinemia Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlantic Medical Group, Clark, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supportive Care

Other

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.

Primary outcomes

  1. Proportion of patients with LDL-C maintenance<100

    Time frame: 6 months from enrollment in study

    LDL-C <100 mg/dL after at least six months of therapy

Secondary outcomes

  1. Proportion of patients with LDL-C reaching <75

    Time frame: 6 months from enrollment in study

    LDL-C <75 mg/DL

  2. Proportion of patients with LDL-C reaching <55

    Time frame: 6 months from enrollment in study

    LDL-C < 55mg/DL

Study contacts

Contact information is provided by the study sponsor or research team.

Jeffrey N Feldman, MD

CONTACT

[email protected]

908-686-9330

Robert D Fishberg, MD

CONTACT

[email protected]

973-467-0005

Sponsors and collaborators

Lead sponsor

Atlantic Health System

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Acronym: ALLTOP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 3, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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