Familial HypercholesterolemiaALLTOPNCT06439654
Atlantic Lipid Lowering Treatment Optimization Program
A study testing Supportive care in people with Familial Hypercholesterolemia and Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, run by Atlantic Health System at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Familial Hypercholesterolemia, Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, Apolipoprotein B 100, Familial Defective
- What is being tested?
- Supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Individuals who are pregnant
- Individuals who are incarcerated
- Individuals with a terminal illness
- Individuals who do not consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Atlantic Medical Group
Clark, New Jersey, 07066
Robert D Fishberg, MD, 973-467-0005, robert.fishberg@atlantichealth.org
Jeffrey N Feldman, MD, 908-686-9330, jeffrey.feldman@atlantichealth.org
- Recruiting
Atlantic Medical Group
Springfield, New Jersey, 07081
Robert D Fishberg, MD, 973-467-0005, robert.fishberg@atlantichealth.org
Jeffrey N Feldman, MD, 908-686-9330, jeffrey.feldman@atlantichealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Familial Hypercholesterolemia, Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, Apolipoprotein B 100, Familial Defective, High Density Lipoprotein Deficiency, Low-Density-Lipoid-Type Hyperlipoproteinemia
- Being tested
- Supportive care
- Keywords
- LDL-C, FH, complex dyslipidemia
- Medical subject headings
- Hyperlipoproteinemia Type II, Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, Hypoalphalipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LDL-C | Other | Most recent LDL-C result Receives: Other: Supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with LDL-C maintenance<100
LDL-C <100 mg/dL after at least six months of therapy
Measured: 6 months from enrollment in study
Secondary outcomes (2)
Proportion of patients with LDL-C reaching <75
LDL-C <75 mg/DL
Measured: 6 months from enrollment in study
Proportion of patients with LDL-C reaching <55
LDL-C < 55mg/DL
Measured: 6 months from enrollment in study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jul 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Familial HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlantic Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Robert Fishberg, Atlantic Health System
- Investigators
- Robert D Fishberg, MD, Principal investigator, Atlantic Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439654
- Sponsor's protocol ID
- 2096455
- Acronym
- ALLTOP
- Status last verified
- Jul 2025
- First submitted
- 28 May 2024
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be disseminated in aggregate.
Publications
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.
PubMed 36031461Myers 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.
PubMed 31331194Khera 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, Farrall M, Watkins H, Lander E, Wilson JG, Correa A, Boerwinkle E, Merlini PA, Ardissino D, Saleheen D, Gabriel S, Kathiresan S. Diagnostic Yield and Clinical Utility of Sequencing Familial Hypercholesterolemia Genes in Patients With Severe Hypercholesterolemia. J Am Coll Cardiol. 2016 Jun 7;67(22):2578-89. doi: 10.1016/j.jacc.2016.03.520. Epub 2016 Apr 3.
PubMed 27050191Amrock 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.
PubMed 29080546Kastelein 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.
PubMed 26330422Alam 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atlantic Lipid Lowering Treatment Optimization Program (ALLTOP): A Comprehensive Approach to the Treatment of Familial Hypercholesterolemia and Complex Dyslipidemias
- ClinicalTrials.gov ID
- NCT06439654
- Acronym / sponsor ID
- ALLTOP / 2096455
- 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
- LDL-C, FH, complex dyslipidemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Atlantic Health SystemUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| LDL-C | Other | Other: Supportive careMost recent LDL-C result |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Individuals who are pregnant
- Individuals who are incarcerated
- Individuals with a terminal illness
- Individuals who do not consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive careThe 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. | Other | LDL-C |
Primary outcome
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
2 secondary outcomes
Proportion of patients with LDL-C reaching <75
Time frame: 6 months from enrollment in study
Proportion of patients with LDL-C reaching <55
Time frame: 6 months from enrollment in study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 36031461Writing 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.
- Background: PubMed 31331194Myers 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.
- Results publication: PubMed 27050191Khera 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, Farrall M, Watkins H, Lander E, Wilson JG, Correa A, Boerwinkle E, Merlini PA, Ardissino D, Saleheen D, Gabriel S, Kathiresan S. Diagnostic Yield and Clinical Utility of Sequencing Familial Hypercholesterolemia Genes in Patients With Severe Hypercholesterolemia. J Am Coll Cardiol. 2016 Jun 7;67(22):2578-89. doi: 10.1016/j.jacc.2016.03.520. Epub 2016 Apr 3.
- Results publication: PubMed 29080546Amrock 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.
- Results publication: PubMed 26330422Kastelein 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.
- Results publicationAlam 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
- Individual participant dataSharing planned: No. De-identified data will be disseminated in aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert D Fishberg, MD principal investigator
Atlantic Health System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive care in people with Familial Hypercholesterolemia and Lipoprotein Types--Lp System Lp(A) Hyperlipoproteinemia, run by Atlantic Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert D Fishberg, MD (973-467-0005, robert.fishberg@atlantichealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with LDL-C maintenance<100 (time frame: 6 months from enrollment in study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06439654, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.