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.

Racial differences in incident heart failure among young adults.

BACKGROUND: The antecedents and epidemiology of heart failure in young adults are poorly understood. METHODS: We prospectively assessed the incidence of heart failure over a 20-year period among 5115 blacks and whites of both sexes who were 18 to 30 years of age at baseline. Using Cox models, we examined predictors of hospitalization or death from heart failure. RESULTS: Over the course of 20 years, heart failure developed in 27 participants (mean [+/-SD] age at onset, 39+/-6 years), all but 1 of whom were black. The cumulative incidence of heart failure before the age of 50 years was 1.1% (95% confidence interval [CI], 0.6 to 1.7) in black women, 0.9% (95% CI, 0.5 to 1.4) in black men, 0.08% (95% CI, 0.0 to 0.5) in white women, and 0% (95% CI, 0 to 0.4) in white men (P=0.001 for the comparison of black participants and white participants). Among blacks, independent predictors at 18 to 30 years of age of heart failure occurring 15 years, on average, later included higher diastolic blood pressure (hazard ratio per 10.0 mm Hg, 2.1; 95% CI, 1.4 to 3.1), higher body-mass index (the weight in kilograms divided by the square of the height in meters) (hazard ratio per 5.7 units, 1.4; 95% CI, 1.0 to 1.9), lower high-density lipoprotein cholesterol (hazard ratio per 13.3 mg per deciliter [0.34 mmol per liter], 0.6; 95% CI, 0.4 to 1.0), and kidney disease (hazard ratio, 19.8; 95% CI, 4.5 to 87.2). Three quarters of those in whom heart failure subsequently developed had hypertension by the time they were 40 years of age. Depressed systolic function, as assessed on a study echocardiogram when the participants were 23 to 35 years of age, was independently associated with the development of heart failure 10 years, on average, later (hazard ratio for abnormal systolic function, 36.9; 95% CI, 6.9 to 198.3; hazard ratio for borderline systolic function, 3.5; 95% CI, 1.2 to 10.2). Myocardial infarction, drug use, and alcohol use were not associated with the risk of heart failure. CONCLUSIONS: Incident heart failure before 50 years of age is substantially more common among blacks than among whites. Hypertension, obesity, and systolic dysfunction that are present before a person is 35 years of age are important antecedents that may be targets for the prevention of heart failure. (ClinicalTrials.gov number, NCT00005130.)

Hand-carried cardiac ultrasound as a tool to screen for important cardiovascular disease in an underserved minority health care clinic.

The disparity in cardiovascular outcomes among racial and social strata may be, in part, because of delayed detection of cardiovascular disease in minority patients. The low cost and portability of hand-carried cardiac ultrasound devices may make screening of underserved patients for cardiac disease feasible. A general internist evaluated 153 patients at a clinic serving an underserved population with a hand-carried cardiac ultrasound device. A total of 27 cases of significant valvular heart disease or ventricular dysfunction were detected in 19 patients (12.4%). Detection of a major cardiac abnormality could not be predicted by cardiac risk factors, age, or chief symptom, whereas patients presenting for new or acute clinic visits were more likely to have an abnormality. The low cost and portability of hand-carried cardiac ultrasound devices may make them important tools for the early detection of cardiovascular disease in minority and underserved populations and, thereby, help to reduce disparities in cardiovascular outcomes.

Treatment of high-risk African American patients: left ventricular dysfunction, heart failure, renal disease, and postmyocardial infarction.

African Americans experience more mortality and morbidity from hypertension-related complications than other racial groups. Although angiotensin-converting enzyme (ACE) inhibitors have clearly been shown to reduce mortality and morbidity in hypertensive white patients with heart failure, renal dysfunction, stroke, and acute myocardial infarction, African American patients have been underrepresented in these trials. The lack of direct evidence of the benefit of ACE inhibitors in these individuals and the suggestion that ACE inhibitors are less efficacious in this group has resulted in a reluctance to use ACE inhibitors in African Americans. However, retrospective analyses in black patients with heart failure and a recent randomized clinical trial in African Americans with renal dysfunction suggest that a regimen based on ACE inhibitors is efficacious in this racial group. Although diuretics remain first-line therapy, data now suggest that ACE inhibitors provide additional benefit and should be considered for use in patients with high-risk complications regardless of race.

Ventricular assist device-associated anti-human leukocyte antigen antibody sensitization in pediatric patients bridged to heart transplantation.

BACKGROUND: Ventricular assist devices (VAD) are associated with the formation of antibodies to anti-human leukocyte antigens (HLA) or sensitization. The incidence and effects of VAD-associated anti-HLA sensitization have not been well studied in the pediatric population. METHODS: A retrospective review of all patients undergoing VAD implant at our institution from 1998 to 2008 was performed. Panel reactive antibody (PRA) results before VAD implant, after VAD implant, and after orthotopic heart transplantation (OHT) were recorded. Patients who became sensitized (PRA for class I and/or II immunoglobulin G antibodies >or= 10%) on VAD support were compared with non-sensitized patients with regard to demographics, diagnosis, device type, and blood product exposure on VAD support. Outcomes after OHT were also compared between groups. RESULTS: VAD support was initiated in 20 patients (median age, 14.4 years), with 75% survival to OHT or recovery. PRA data before and after VAD implant were available for 17 patients. VAD-associated sensitization developed in 35% of recipients. There were no differences between those sensitized in association with VAD support and non-sensitized patients with regard to age, gender, diagnosis, device type, extracorporeal membrane oxygenation use, or blood product exposure on VAD support. Black race predicted sensitization on VAD (p = 0.02). There were no differences in survival or rejection between groups. CONCLUSIONS: VAD therapy was associated with the development of anti-HLA sensitization in 35% of recipients. Black race predicted sensitization, but there were no differences in overall survival or outcomes after OHT.

The relative effects of left ventricular hypertrophy, coronary artery disease, and ventricular dysfunction on survival among black adults.

OBJECTIVE: To evaluate the effect of echocardiographically determined left ventricular hypertrophy (LVH) on survival in comparison with number of stenosed vessels and left ventricular systolic dysfunction. DESIGN: Cohort study based on a consecutive sample from a hospital registry, with a mean follow-up of 5 years. SETTING: An inner-city public hospital in Chicago, Ill. PATIENTS: The study included 1089 consecutive black patients who underwent both coronary angiography and M-mode echocardiography as part of a diagnostic evaluation. RESULTS: Nonstenosed coronary arteries, single-vessel disease, and multivessel disease were found in 48%, 16%, and 36% of patients, respectively; LVH (left ventricular mass index > 131 g/m2 in men and > 100 g/m2 in women) was detected in 50% of patients. Hypertrophy without coexistent obstructive coronary disease was associated with a lower survival rate than that observed for single-vessel disease and was similar to multivessel disease. When LVH, number of diseases vessels, and left ventricular dysfunction were subjected to multivariate analysis, hypertrophy conferred a relative risk (RR) of 2.4 (95% confidence interval [CI], 1.7 to 3.2). By comparison, the presence of a single stenosed vessel did not increase the risk of death. Multivessel disease and ejection fraction less than 45% were associated with an RR of 1.6 (95% CI, 1.1 to 2.2) and 2.0 (95% CI, 1.4 to 2.7), respectively. Calculation of the attributable risk fraction demonstrated that for every 100 deaths in this cohort, LVH independently accounted for 37. The corresponding attributable risk fractions were 1%, 22%, and 9% for single-vessel disease, multivessel disease, and ventricular dysfunction, respectively. CONCLUSIONS: Left ventricular hypertrophy was associated with a greater RR and attributable risk than the traditional measures of coronary disease severity. The high prevalence and powerful risk of LVH make an important contribution to the adverse survival rates among black patients with heart disease and may account for much of the black-white differential.