Black participants less represented in US heart failure registries than in clinical trials
This systematic review and meta-analysis compared racial representation in US-based heart failure clinical trials and registries from 2010 to 2019. The analysis included 62 trials and 15 registries, with 45 trials and 10 registries providing granular racial data. The primary outcome was the proportion of underrepresented racial and ethnic groups, with specific focus on Black and non-White participants.
The main finding was that Black participants were significantly less represented in heart failure registries (21.8%, 95% CI: 17.2-27.3%) than in clinical trials (30.4%, 95% CI: 26.1-35.1%), with a P value of 0.016. For non-White participants, registries showed a lower percentage compared to trials, but this difference was not statistically significant (P=0.25). The study did not report absolute numbers of participants or effect sizes for these comparisons.
No safety or tolerability data were reported, as the analysis focused solely on enrollment patterns. Key limitations include the observational nature of the comparison, which shows association but not causation. The study does not establish why representation differs between trial and registry settings, nor does it assess clinical outcomes related to representation. The findings are limited to US-based studies from 2010-2019. Practice relevance was not explicitly reported, but the data suggest clinicians should be aware of potential differences in patient populations between trial and real-world registry settings.