Researchers for the study performed a systematic search of HF trials that enrolled more than 400 patients between 2001 and 2016 (the review ended up looking at data from 118 trials). A cumulative total of 215,508 patients were included in the analysis, and findings were compared with large epidemiological studies.
According to the results, about 27% (58,873 of 215,508 participants) were women. Older patients tended to be enrolled in chronic HF with preserved ejection fraction. The data also showed a higher proportion of women in trials of HF with preserved ejection fraction vs. those looking at reduced ejection fraction. In addition, the distribution of racial/ethnic groups was only reported in 55% of the studies surveyed (22% of participants were not white). There was a significant increase over time in enrollment of racial/ethnic group distribution over time, going from 13% in 2001-04 to 30% in 2013-16 (P=0.01).
“In contemporary HF trials, older patients and women are consistently underrepresented,” the researchers wrote in their study. “Race/ethnicity data are reported in less than half of trials; when reported, such data show that enrollment of nonwhite patients has increased over time.”
Great analysis: In HF trials, #older #patients and #women are STILL consistently underrepresented. #Race/#ethnicity #data are reported in less than half of clinical #trials. BIG NEED for ACTION!!! @WomenHeartOrg @MayoClinicCV @SharonneHayes https://t.co/b6TV4UVwpn
— Tanja Dudenbostel, MD, FASH, FAHA (@DrDudenbostel) August 22, 2018
How has enrollment of older patients, women, and racial/ethnic minorities in #heartfailure trials changed over time? Now published in @JAMACardio https://t.co/YpZkRjGFaF@Ayman__Tahhan @mvaduganathan @gcfmd @coconnormd @mfiuzat @JavedButler1 @DCRINews @DukeMedSchool pic.twitter.com/DWZZmAyDOy
— Steve Greene (@SJGreene_md) August 22, 2018
Enrollment trends of older patients, women, and racial/ethnic minorities in HF trials. Now published in @JAMACardio @mvaduganathan @SJGreene_md @gcfmd @mfiuzat @jesse8850 @gcfmd @coconnormd @mfiuzat @JavedButler1 @EmoryCCRI @EmoryMedicine @emoryheart
— Ayman Tahhan (@Ayman__Tahhan) August 23, 2018
Diverse populations must be represented in clinical trials to ensure that treatments are effective and safe for everyone https://t.co/rmfQ7gwom5
— Jenna Kay (@jennakaymd) August 24, 2018
Source: JAMA Cardiology