A study to better understand the association between Lipoprotein(a), Lp(a) levels and artherosclerotic cardiovascular disease (ASCVD) in an underrepresented population has been announced by Amgen, which will collaborate with the Association of Black Cardiologists and the Morehouse School of Medicine on the African American Heart Study. Photo credit: Getty Images
March 8, 2023 — A unique community-based partnership, the African American Heart Study, will be conducted to measure the association between Lipoprotein(a), or Lp(a), and atherosclerotic cardiovascular disease (ASCVD) in 5,000 African American individuals across the United States. Amgen recently announced the study and its collaboration with the Association of Black Cardiologists (ABC) and the Morehouse School of Medicine (MSM) to better assess ASCVD — defined as the buildup of cholesterol plaque in arteries which includes events such as heart attack and stroke, in an underrepresented population.
“The African American Heart Study is a unique collaborative study including community outreach in partnership with trusted organizations to help improve our understanding of the disproportionate higher incidence of Lp(a) and cardiovascular disease progression in African Americans and hopefully provide insights of ways to address barriers in clinical trial access,” said Ponda Motsepe-Ditshego, M.D., vice president, global medical and head of Amgen’s Representation in Clinical Research team.
Cardiovascular disease is the number one killer of all Americans, and the cardiovascular risk for African Americans is even higher. According to the U.S. Department of Health and Human Services, African Americans are 30% more likely to die from heart disease than non-Hispanic whites. [i]-ii]
"People of all races and ethnicities can have high levels of Lp(a), but it appears to be more common in African Americans," said principal investigator in the study is Elizabeth Ofili, M.D., M.P.H., FACC, professor of medicine at Morehouse School of Medicine. Ofili added, "I am excited about the African American Heart Study because we have the opportunity to study up to 5,000 self-identified African Americans, who have been so often underrepresented in studies, in order to gain a better understanding of the genetic underpinnings of Lp(a) and to determine if African American patients are at a higher risk of cardiovascular disease. The results of this study will potentially provide insights that will help determine which types of patients would benefit most from future therapy.”
This prospective case-control study design will enroll 2,500 self-identified African Americans with ASCVD and 2,500 self-identified African Americans without ASCVD from cardiology and primary care practices across the United States. Enrollment is voluntary. ABC and MSM will conduct community outreach, as well as identify sites through the Health 360x Clinical Trial Network and Registry. The Health 360x Network practice sites are trusted providers, crucial to the success of the African American Heart Study. The Health 360x Clinical Trial Network and Registry is funded by the National Institutes of Health to support clinical trials in community-based practices.9
The main objective of the study is to determine associations between Lp(a) levels, sequence variants, clinical factors and cardiovascular outcomes in African Americans. Participants will be followed for at least three years leveraging real-world evidence from electronic health records.
Amgen's subsidiary, deCODE genetics, based in Reykjavik, Iceland, with its world-class human genetics capabilities, will sequence and analyze DNA, RNA, and protein markers from participants' blood samples. With three years of follow-up planned, the broad omics data analyzed by deCODE will help Amgen broaden the understanding of ASCVD and other diseases that disproportionately affect African Americans. The learnings may also inform future clinical trials and drug development.
“Increasing the diversity in our clinical trials is essential to achieving our ambition of serving all patients. This requires us to think differently than we have in the past about how we design and conduct our trials,” said Rob Lenz, M.D., Ph.D., senior vice president, Global Development at Amgen. “To do that, we are educating the community on why this is critical and building trusted relationships with our partners. We also are training external investigators and building new capabilities that will help provide them with the right infrastructures in communities of underserved patient populations to make projects like the African American Heart Study possible.”
Lp(a) is genetically determined and presumed to be an independent risk factor for cardiovascular disease (CVD). 4-6 Although an agreed upon threshold for elevated Lp(a) is not firmly established, it has been estimated that approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).3-6 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.3-8
Lp(a) is a presumed independent risk factor for heart disease; levels are genetically determined and are known to differ by race and ethnicity.3-6 African American individuals show a higher average Lp(a) concentration than white populations, but Lp(a) research to date has primarily been conducted in individuals of European descent.7 A news release announcing the program noted that this leaves the association between Lp(a) levels and incident ASCVD in persons of African American descent uncertain, and important to investigate further to understand drivers of cardiovascular risk in African Americans, adding that Thousand Oaks, CA-based biotech company Amgen has initiated the African American Heart Study to bridge this gap.
For more information:
[i] American Heart Association. African Americans and Heart Disease, Stroke. Available at: https://www.heart.org/en/health-topics/consumer-healthcare/what-is-cardiovascular-disease/african-americans-and-heart-disease-stroke. Last accessed: February 9, 2023.
[ii] CDC. Lipoprotein (a). Available at: https://www.cdc.gov/genomics/disease/lipoprotein_a.htm#:~:text=High%20levels%20of%20lipoprotein%20(a,made%20of%20protein%20and%20fat. Last accessed: February 9, 2023.
3 Wilson DP, et al. Clin Lipidol. 2019;13:374-92.
4 Reyes-Soffer G, et al. Arterioscler Thromb Vasc Biol. 2022;42:e48-e60.
5 Tsimisas S, et al. J Am Coll Cardiol. 2018;71:177-192
6 Kronenberg F, et al. Eur Heart J. 2022; 43:3935-3946.
7 Tsimikas S, et al. J Am Coll Cardiol. 2022;80:934-946.
8 Tsmikas S, et al. J Am Coll Cardiol. 2017;69:692-711.
9 Health 360x Clinical Research Platform for Scalable Access to Clinical Trials is funded by the National Center for Advancing Translational Science, National Institutes of Health, Small Business Innovation Research Award # 5R44TR003832 (PI Chamberlain Obialo, MD, AccuHealth Technologies Inc.) The content of the Press Release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.