Abstract 15755: Clinical Trials Associated With Heart Failure Guidelines Are Not Generalizable to Black Populations
Introduction: Black individuals have a higher incidence of heart failure (HF) and suffer worse outcomes relative to white individuals. Inclusion of black patients in major randomized clinical trials (RCTs) for HF, however, has been modest and questions remain regarding differential treatment effect as a function of race. The aim of this study is to determine the inclusion of black participants in HF clinical trials that have informed treatment guidelines and to ascertain enrollment goals for black individuals to improve generalizability in future HF studies.
Methods: RCTs for HF pharmacotherapy were identified from PubMed, www.trialresultscenter.org and the 2013 ACCF/AHA guidelines for HF treatment. Median enrollment of individuals identified as black was analyzed. Based on hazard ratios of mortality from prior RCTs, we proposed a theoretical RCT (N=8,000) to illustrate potential statistical power of black subpopulation analyses. Power curves were generated across varying proportions of black participants.
Results: A total of 47 RCTs (N=85,572) were included. The median percentage of black study participants enrolled was 5.1%. The percentage of studies that reported the race of enrolled patients was 61.7% and 29.5% reported outcomes by race. In the theoretical model, 5%, 13%, and 26% black enrollment yielded a power of 0.3, 0.6 and 0.9 respectively, to detect a 20% treatment effect. In the model among the same proportion of black patients, the power to detect a 10% treatment effect was 0.1, 0.2 and 0.4. (Fig. 1)
Conclusions: Guideline-based clinical trials for HF therapeutics have had poor enrollment of black participants and were unlikely to detect potential treatment differences in blacks. Enrollment goals for black individuals in large HF therapeutics trials should approach the disease prevalence in those populations at greatest risk.
Author Disclosures: L.T. Sullivan: None. T. Randolph: None. C. Egwim: None. P. Merrill: None. K.L. Thomas: None.
- © 2016 by American Heart Association, Inc.