Improving Enrollment of Underrepresented Racial and Ethnic Populations in Heart Failure Trials

Abstract

ome racial and ethnic populations, particularly Black and Hispanic individuals, have a greater burden of heart failure (HF), are less likely to receive optimal disease-modifying therapies, and are more likely to die from HF. [1][2][3][4][5] Despite this excess risk, these same populations are often the least studied in HF clinical trials. [6][7][8][9][10] The importance of addressing the systemic underenrollment of some racial and ethnic groups has been previously highlighted 11 and remains an important directive of the US Food and Drug Administration (FDA) Safety and Innovation Act as well as the Inclusion Policy of the National Institutes of Health (NIH). 12 The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance therapeutic development and delivery to patients with HF, 13 has been dedicated to improving recruitment strategies for diverse patient populations. This article is the direct result of virtual and in-person discussions among Collaboratory stakeholders with the goal of proposing strategies to improve enrollment in HF clinical trials of underrepresented racial and ethnic groups. We focus on the US perspective in the HF clinical trial landscape (with specific attention to enrollment of Black and Hispanic participants) and highlight US federal policies and initiatives to promote improved racial and ethnic representation. We recognize the need as well for improving enrollment of other populations of interest, including women, older adults, and people in rural areas of the United States [14][15][16][17] ; however, this call to action focuses on building sustainable pathways to improve future diverse participation with respect to race and ethnicity. Barriers in Underrepresented HF Trial EnrollmentMany racial and ethnic populations continue to experience socioeconomic deprivation, chronic discrimination, and stress that worsen health outcomes across the lifespan. [18][19][20][21] The ability and willingness of patients with HF to actively participate in clinical trials is intricately tied to social determinants of health, such as access to health care, education, income equality, and food security as well as cultural and community values. 22 This underrepresentation likely results from limited access both to clinical care and the current clinical IMPORTANCE Despite bearing a disproportionate burden of heart failure (HF), Black and Hispanic individuals have been poorly represented in HF clinical trials. Underrepresentation in clinical trials limits the generalizability of the findings to these populations and may even introduce uncertainties and hesitancy when translating trial data to the care of people from underrepresented groups. The Heart Failure Collaboratory, a consortium of stakeholders convened to enhance HF therapeutic development, has been dedicated to improving recruitment strategies for patients from diverse and historically underrepresented groups.OBSERVATIONS Despite federal policies from the US Food and Drug Administration and National Institutes of Health aimed at i...

Tipping the scale toward a more accurate and equitable assessment of heart failure with reduced ejection fraction pharmacotherapy eligibility: a call to incorporate cystatin C in estimating glomerular filtration rate

“…Furthermore, there has been an extensive history of under-enrolment of Black patients into HFrEF clinical trials. 16 Results from the current analysis reveal that use of the 2021 eGFRcr equation may further increase racial disparities by limiting both the use of guideline-directed medical therapy and future HFrEF trial eligibility in Black patients with HFrEF and advanced CKD. It is important to acknowledge that incorporation of cystatin C into eGFR calculations will not correct the vast racial inequities in the clinical care and trial enrolment of Black patients with HFrEF.…”

“…Black patients with HFrEF have higher rates of hospitalization and death due to a variety of reasons, including socioeconomic factors as well as unequal access to health care. Furthermore, there has been an extensive history of under‐enrolment of Black patients into HFrEF clinical trials 16 . Results from the current analysis reveal that use of the 2021 eGFRcr equation may further increase racial disparities by limiting both the use of guideline‐directed medical therapy and future HFrEF trial eligibility in Black patients with HFrEF and advanced CKD.…”

“…Results from the current analysis reveal that use of the 2021 eGFRcr equation may further increase racial disparities by limiting both the use of guideline‐directed medical therapy and future HFrEF trial eligibility in Black patients with HFrEF and advanced CKD. It is important to acknowledge that incorporation of cystatin C into eGFR calculations will not correct the vast racial inequities in the clinical care and trial enrolment of Black patients with HFrEF 16 . However, use of the eGFRcr‐cys equation represents a formidable step, as it is race‐neutral, accurate, and may result in more equitable care.…”

“…16 However, use of the eGFRcr-cys equation represents a formidable step, as it is race-neutral, accurate, and may result in more equitable care. The last iteration of American Heart Association/American College of Cardiology and the European Society of Cardiology heart failure guidelines were written prior to the development of the 2021 eGFRcr-cys equation and do not discuss incorporation of cystatin C in patients with CKD.…”

Collab, Virtualize, Democratize: A Conversation With the Founders of CardioNerds

“…Early success has been driven by the FITTs, principal investigator mentors, and patients who partnered together to move cardiovascular science forward. 5 We are looking forward to studying this program in detail to learn from our experience as we consider the next steps in expanding the CardioNerds Clinical Trials Network.…”