Certain populations remain underrepresented in heart failure clinical trials

Older patients, women, and racial and ethnic minorities carry a disproportionate burden of heart failure in the general population, but their enrollment in clinical trials has been lower than expected. These findings have raised concerns about the generalizability of heart failure trials. Given important biological differences by age, sex, and race/ethnicity, the risks and benefits of tested therapies may differ based on demographic profiles. In a systematic review of 118 heart failure clinical trials from 2001 to 2016, researchers recently found that the average age of participants was 65 years and 27% were women, suggesting that older patients and women are consistently underrepresented. Race or ethnicity data were reported in less than half of trials, and when reported, such data showed that enrollment of nonwhite patients increased steadily from 13% to 30% over time. According to the authors, future efforts should focus on improving the reporting of age, sex, and race/ethnicity data in heart failure clinical trials and enhancing the representativeness of trial populations. The study, which was partly funded by the NHLBI, was published in the journal JAMA Cardiology.