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Black participants less represented in US heart failure registries than in clinical trials

Black participants less represented in US heart failure registries than in clinical trials
Photo by Marek Studzinski / Unsplash
Key Takeaway
Note that Black patient representation differs between US heart failure trials and registries.

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.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedApr 2026
View Original Abstract ↓
BACKGROUND: Underrepresented racial and ethnic group (UREG) participation in heart failure (HF) clinical trials has not historically represented the disproportionate high burden in those communities. HF registries may include more UREGs based on broader inclusion criteria and observational nature. OBJECTIVES: Study objective was to examine the proportion of UREGs participating in HF trials compared to HF registries using a systematic review and meta-analysis. METHODS: We searched both PubMed and Embase for randomized controlled HF trials and registries completed between 2010-2019 based in the United States. A total of 2124 articles were identified and screened for inclusion. Secondary information was supplemented by Clinicaltrials.gov and/or representative publications. The percentages of different races within included HF trials and registries were calculated and quantitative meta-analyses were performed to compare enrollment percentages between trials and registries. RESULTS: This review included 62 trials and 15 registries of which 45 (72.6%) trials and 10 (66.7%) registries reported granular racial groups rather than aggregated racial categories. Black participants were significantly less represented in HF registries (21.8%, 95% CI: 17.2-27.3%) compared to clinical trials (30.4%, 95% CI: 26.1-35.1%; P=0.016). Registries also demonstrated a lower percentage of non-White participants (18.0%, 95% CI: 11.1-27.7%) compared with trials (24.3%, 95% CI: 18.7-31.0%; P=0.25); however, the difference was not statistically significant. CONCLUSIONS: Black participants were significantly less represented in HF registries than trials despite the observational nature of registries. Contrary to our hypothesis, HF registries included in this systematic review did not yield higher inclusion rates of Black and non-White HF patients compared to clinical trials.
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