Representation of black patients in randomized clinical trials of heart failure with reduced ejection fraction.

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.

Global Variations in Patient Populations and Outcomes in Heart Failure Clinical Trials.

PURPOSE OF REVIEW: Heart failure is a global pandemic and there has been a growing effort to enroll patients from different geographical regions in randomized controlled trials. In this review, we examined regional variation in both patient characteristics and outcomes among several of the most recent global heart failure trials RECENT FINDINGS: Retrospective analyses of global heart failure trials have identified marked variations in both baseline characteristics and management of heart failure by region of enrollment. In some trials, this variation has been significant enough to cause differential treatment effects. We summarized key heterogeneity observed in global heart failure clinical trials. Differences in both patient population and organization of these trials abroad pose an important challenge in making interpretations and country-level decisions. As such, we encourage a concerted effort to account for these differences in future research.

Research Participation of a Professional Organization in Clinical Trials: The Association of Black cardiologists Clinical Trial Investigator Identification Project.

INTRODUCTION: Black individuals continue to be underrepresented in clinical trials despite efforts by the National Institutes of Health and the Federal Drug Administration to increase their enrollment. Health care providers play a critical role in the recruitment of patients into clinical trials, as they have established relationships and are uniquely positioned to make referrals for participation. While prior initiatives have focused on training black physicians to conduct clinical research, we sought to determine the potential of utilizing a professional organization as a resource to identify established investigators to champion recruitment of underrepresented racial and ethnic populations. The Association of Black Cardiologists (ABC) is a non-profit organization with a mission to eliminate racial and ethnic disparities in cardiovascular disease and may provide a conduit for recruiting investigators. The purpose of this study was to examine the feasibility of using the ABC membership to identify investigators with an established track record in clinical trials. METHODS/RESULTS: Utilizing a roster of ABC members, we searched Scopus to quantify ABC member publications from 1999 to 2015 and identify members who have been active in clinical trials. Within the membership of 2037 individuals, we identified 794 with peer-reviewed publications, and 109 who co-authored manuscripts involving randomized clinical trials. The manuscripts largely focused on hypertension and heart failure, conditions that have a disproportionately greater affect on black individuals. CONCLUSION: Members of the ABC have varied amounts of research productivity. We identified a group of experienced investigators to engage in efforts aimed at recruiting/enrolling underrepresented racial and ethnic populations in clinical trials of cardiovascular disease.

Associations Between Blood Pressure and Outcomes Among Blacks in the Jackson Heart Study.

BACKGROUND: In 2014, new hypertension guidelines liberalized blood pressure goals for persons 60 years and older. Little is known about the implications for blacks. METHODS AND RESULTS: Using data from 2000 through 2011 for 5280 participants in the Jackson Heart Study, a community-based black cohort in Jackson, Mississippi, we examined whether higher blood pressure was associated with greater risk of mortality and heart failure hospitalization, and whether the risk was the same across age groups. We investigated associations between baseline blood pressure and both mortality and heart failure hospitalization. We also tested for interactions between age and blood pressure in the mortality model. Median systolic and diastolic blood pressures at baseline were 125 mm Hg (25th-75th percentile, 114-137 mm Hg) and 79 mm Hg (72-86 mm Hg), respectively. Median follow-up was 9 years for mortality and 7 years for heart failure hospitalization. After multivariable adjustment, every 10 mm Hg increase in systolic blood pressure was associated with greater risks of mortality (hazard ratio, 1.12; 95% CI, 1.06-1.17) and heart failure hospitalization (1.07; 95% CI, 1.00-1.14). The mortality risk per 10 mm Hg increase in systolic blood pressure was greater in participants younger than 60 years (1.26; 95% CI, 1.13-1.42) than among participants 60 years and older (1.09; 95% CI, 1.03-1.15). CONCLUSIONS: Adults in all age groups were at greater risk of mortality as systolic blood pressure increased. In the context of the 2014 hypertension guidelines, these findings should be considered when determining treatment goals in black patients.