Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP)

July 30, 2025 updated by: Robert Fishberg, Atlantic Health System

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • Clark, New Jersey, United States, 07066
        • Not yet recruiting
        • Atlantic Medical Group
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert D Fishberg, MD
        • Sub-Investigator:
          • Jeffrey N Feldman, MD
        • Sub-Investigator:
          • Deatrah Dubose, NP
        • Sub-Investigator:
          • Matthew Proute, MD
        • Sub-Investigator:
          • Nosagie Ohonba, MD
        • Sub-Investigator:
          • Tiffany Haynes, MD
        • Sub-Investigator:
          • Anusha Ramasray, MD
      • Springfield, New Jersey, United States, 07081
        • Recruiting
        • Atlantic Medical Group
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert D Fishberg, MD
        • Sub-Investigator:
          • Jeffrey N Feldman, MD
        • Sub-Investigator:
          • Deatrah Dubose, NP
        • Sub-Investigator:
          • Matthew Proute, MD
        • Sub-Investigator:
          • Nosagie Ohonba, MD
        • Sub-Investigator:
          • Tiffany Haynes, MD
        • Sub-Investigator:
          • Anusha Ramasray, MD
        • Sub-Investigator:
          • Anjali Kakwani, PharmD
        • Sub-Investigator:
          • Cassidy Maggio, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LDL-C
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months from enrollment in study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with LDL-C reaching <75
Time Frame: 6 months from enrollment in study
LDL-C <75 mg/DL
6 months from enrollment in study
Proportion of patients with LDL-C reaching <55
Time Frame: 6 months from enrollment in study
LDL-C < 55mg/DL
6 months from enrollment in study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Principal Investigator: Robert D Fishberg, MD, Atlantic Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria

May 28, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2096455

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified data will be disseminated in aggregate.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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