Lonnie T Sullivan1, Tiffany Randolph2, Peter Merrill3, Larry R Jackson1, Chidiebube Egwim4, Monique A Starks3, Kevin L Thomas5. 1. Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. 2. Cone Health Medical Group, Greensboro, NC. 3. Duke Clinical Research Institute, Durham, NC. 4. Duke University Medical Center, Durham, NC. 5. Duke University Medical Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: kevin.thomas@duke.edu.
Abstract
BACKGROUND: Black individuals have a disproportionately higher burden of heart failure with reduced ejection fraction (HFrEF) relative to other racial and ethnic populations. We conducted a systematic review to determine the representation, enrollment trends, and outcomes of black patients in historic and contemporary randomized clinical trials (RCTs) for HFrEF. METHODS: We searched PubMed and Embase for RCTs of patients with chronic HFrEF that evaluated therapies that significantly improved clinical outcomes. We extracted trial characteristics and compared them by trial type. Linear regression was used to assess trends in enrollment among HFrEF RCTs over time. RESULTS: A total of 25 RCTs, 19 for pharmacotherapies and 6 (n=9,501) for implantable cardioverter defibrillators, were included in this analysis. Among these studies, there were 78,816 patients, 4,640 black (5.9%), and the median black participation per trial was 162 patients. Black race was reported in the manuscript of 14 (56.0%) trials, and outcomes by race were available for 12 (48.0%) trials. Implantable cardiac defibrillator trials enrolled a greater percentage of black patients than pharmacotherapy trials (7.1% vs 5.7%). Overall, patient enrollment among the 25 RCTs increased over time (P = .075); however, the percentage of black patients has decreased (P = .001). Outcomes varied significantly between black and white patients in 6 studies. CONCLUSIONS: Black patients are modestly represented among pivotal RCTs of individuals with HFrEF for both pharmacotherapies and implantable cardioverter defibrillators. The current trend for decreasing black representation in trials of HF therapeutics is concerning and must improve to ensure the generalizability for this vulnerable population.
BACKGROUND: Black individuals have a disproportionately higher burden of heart failure with reduced ejection fraction (HFrEF) relative to other racial and ethnic populations. We conducted a systematic review to determine the representation, enrollment trends, and outcomes of black patients in historic and contemporary randomized clinical trials (RCTs) for HFrEF. METHODS: We searched PubMed and Embase for RCTs of patients with chronic HFrEF that evaluated therapies that significantly improved clinical outcomes. We extracted trial characteristics and compared them by trial type. Linear regression was used to assess trends in enrollment among HFrEF RCTs over time. RESULTS: A total of 25 RCTs, 19 for pharmacotherapies and 6 (n=9,501) for implantable cardioverter defibrillators, were included in this analysis. Among these studies, there were 78,816 patients, 4,640 black (5.9%), and the median black participation per trial was 162 patients. Black race was reported in the manuscript of 14 (56.0%) trials, and outcomes by race were available for 12 (48.0%) trials. Implantable cardiac defibrillator trials enrolled a greater percentage of black patients than pharmacotherapy trials (7.1% vs 5.7%). Overall, patient enrollment among the 25 RCTs increased over time (P = .075); however, the percentage of black patients has decreased (P = .001). Outcomes varied significantly between black and white patients in 6 studies. CONCLUSIONS: Black patients are modestly represented among pivotal RCTs of individuals with HFrEF for both pharmacotherapies and implantable cardioverter defibrillators. The current trend for decreasing black representation in trials of HF therapeutics is concerning and must improve to ensure the generalizability for this vulnerable population.
Authors: Meena Khan; Andre Stone; Ryan J Soose; Samuel M Cohen; Javier Howard; Robson Capasso; Deeyar Itayem; M Boyd Gillespie; Reena Mehra; Eugene Chio; Patrick J Strollo; Anna Menzl; Adam Kaplan; Quan Ni Journal: J Clin Sleep Med Date: 2022-09-01 Impact factor: 4.324
Authors: Kevin S Shah; Adriana E Reyes-Miranda; Steven M Bradley; Khadijah Breathett; Sandeep R Das; Ty J Gluckman; Divya Gupta; Daniel T Leung; R Kannan Mutharasan; Pamela N Peterson; Emily S Spivak; Rashmee U Shah Journal: J Racial Ethn Health Disparities Date: 2022-04-05