Physiology and Developmental Biology
First Faculty Advisor
Len Novilla, MD, MPH
First Faculty Reader
Fatima Rodriguez, MD, MPH
Second Faculty Reader
Ashish Sarraju, MD
Roy Silcox, PhD
Heart Failure, Clinical Trials, Racial/ Ethnic Representation
Heart failure (HF) is a common cause of morbidity and mortality in the United States that may disproportionately affect certain racial/ethnic groups. Compared with White individuals, HF may affect Black individuals at a younger age with less favorable prognosis, and this excess risk may be partially explained by differences in HF risk factor burden. It is crucial for guideline informing HF clinical trials to adequately reflect the racial/ethnic diversity in the population. We assessed the extent of reporting and representation of race/ethnicity in HF clinical trials referenced in the 2013 ACC/AHA Guideline for the Management of Heart Failure and the 2017 ACC/AHA/HFSA Focused Update. All randomized clinic trials referenced in these guidelines were included. The prevalence of reporting of race/ethnicity, the proportions of racial/ethnic subgroups enrolled, and subgroup analysis based on intervention type – pharmacologic, device, and other – were evaluated. A total of 265 trials (547,353 subjects) were included in the study which were published between 1950 and 2018. Among these, only 99 trials reported any race/ethnicity (37.4%), 97 reported white race (36.6%), 57 reported Black race (21.5%), 15 reported Hispanic ethnicity (5.7%), and 24 reported Asian race (9.1%). In trials reporting white, black, Hispanic, and Asian race/ethnicity respectively, 77.8% (n = 248,321/319,070) of patients were white, 12.3% (n = 29,353/239,192) of patients were black, 11.0% (n = 8,374/76,099) of patients were Hispanic, and 9.7% (n = 15,063/155,577) of patients were Asian. Clinical trials that dictate clinical care of patients with HF through informing contemporary ACC/AHA HF guidelines under-represent Black and Hispanic populations. Additionally, two-thirds of trials fail to report any race/ ethnicity at all. Guideline and practice-informing clinical trials need to improve the representation of minority populations to provide clinicians with generalizable data.
BYU ScholarsArchive Citation
Gamino, Gerardo, "Racial and Ethnic Minority Groups Are Under-Represented and Under-Reported in Guideline-Informing Heart Failure Clinical Trials" (2021). Undergraduate Honors Theses. 200.